Clinical trial NCT00734474: A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
Official title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes, type 2 diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: United BioSource, LLC
name: Tessella Inc.
name: Berry Consultants
First posted: 2008-08-14
Enrollment: 1202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.

Detailed description: This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to 26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3 portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if 2 doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin (HbA1c) at 52 weeks. The final endpoint is 104 weeks.

Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265 doses until a dose decision is made based on quantitative analysis of the benefits and risks of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this end. After the dose decision, participants in the selected LY2189265 arms and the comparator arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional participants will be randomized to the selected and comparator arms. Regardless of the timing of randomization relative to the dose decision point, all participants in the selected and comparator arms are planned to receive treatment for 104 weeks; participants in the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain blinded to their study treatment throughout the study. Participants in the non-selected arms will discontinue from the study after the dose decision

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus, type 2, for at least 6 months
* Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.
* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of \>8.0% to ≤9.5%
* Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m\^2), inclusive
* Stable weight for 3 months prior to screening
* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method

Exclusion Criteria:

* Diabetes mellitus, type 1
* Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin
* Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility
* Use of medications to promote weight loss
* Clinically-relevant cardiovascular event within 6 months prior to screening
* Poorly controlled hypertension
* Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease
* Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels \>3.0 times the upper limit of normal
* Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance \<60 milliliters per minute (mL/minute)
* Uncontrolled diabetes, defined as \>2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.
* Uncontrolled endocrine or autoimmune abnormality
* History of a transplanted organ
* Chronic use of systemic glucocorticoid therapy
* Active or untreated malignancy
* Use of central nervous system (CNS) stimulants

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c) Change From Baseline
timeFrame: Baseline, 52 weeks
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point
timeFrame: Baseline up to 27.4 weeks
measure: Glycosylated Hemoglobin (HbA1c) Change From Baseline
timeFrame: Baseline, 26 weeks, 104 weeks
measure: Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 13, 26, 52, and 104 weeks
measure: Fasting Blood Glucose Change From Baseline
timeFrame: Baseline, 26, 52, and 104 weeks
measure: Fasting Insulin Change From Baseline
timeFrame: Baseline, 26, 52, and 104 weeks
measure: Change From Baseline in Body Weight at Dose Decision Point
timeFrame: Baseline up to 27.4 weeks
measure: Body Weight Change From Baseline
timeFrame: Baseline, 26, 52, and 104 weeks
measure: Durability of Change From Baseline Body Weight
timeFrame: Baseline, 13, 26, 52, and 104 weeks
measure: Waist Circumference Change From Baseline
timeFrame: Baseline, 26, 52, and 104 weeks
measure: Percentage of Participants Who Achieve Glycosylated Hemoglobin (HbA1c) <7% or ≤6.5%
timeFrame: Baseline, 26, 52, and 104 weeks
measure: Incidence of Hypoglycemic Episodes
timeFrame: Baseline through 26 and 104 weeks
measure: Rate of Hypoglycemic Episodes
timeFrame: Baseline through 26 and 104 weeks
measure: Beta Cell Function and Insulin Sensitivity (HOMA2)
timeFrame: Baseline, 26, 52, and 104 weeks
measure: Number of Participants With Treatment-emergent Adverse Events at 26 Weeks
timeFrame: Baseline through 26 weeks
measure: Number of Participants With Treatment-emergent Adverse Events at 52 Weeks
timeFrame: Baseline through 52 weeks
measure: Number of Participants With Treatment-emergent Adverse Events at 104 Weeks
timeFrame: Baseline through 104 weeks
measure: Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 26 Weeks
timeFrame: Baseline through 26 weeks
measure: Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 52 Weeks
timeFrame: Baseline through 52 weeks
measure: Number of Participants With Treatment-emergent Abnormal Laboratory Tests at 104 Weeks
timeFrame: Baseline through 104 weeks
measure: Number of Participants With Treatment-emergent Abnormal Lipid Tests
timeFrame: Baseline through 26 and 104 weeks
measure: Change From Baseline in Pulse Rate at Dose Decision Point
timeFrame: Baseline up to 27.4 weeks
measure: Change From Baseline in Blood Pressure at Dose Decision Point
timeFrame: Baseline up to 27.4 weeks
measure: Change From Baseline in Pulse Rate
timeFrame: Baseline, 26 weeks, 104 weeks
measure: Change From Baseline in Blood Pressure
timeFrame: Baseline, 26 weeks, 104 weeks
measure: Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia-corrected QT (QTcF) and PR Interval
timeFrame: Baseline, 26 weeks, 104 weeks
measure: Participant-reported Outcomes, Impact of Weight on Quality of Life-Lite (IWQoL-Lite)
timeFrame: Baseline, 52 weeks, and 104 weeks
measure: Participant-reported Outcomes, EQ-5D
timeFrame: Baseline, 52 weeks, and 104 weeks
measure: Resource Utilization
timeFrame: Baseline through 52 and 104 weeks
measure: Pharmacokinetics of LY2189265: Area Under the Concentration-Time Curve
timeFrame: Baseline through 52 weeks
measure: Antibodies to LY2189265
timeFrame: Baseline through 104 weeks
Other outcomes:
measure: Number of Participants With Adjudicated Pancreatitis at 104 Weeks
timeFrame: Baseline through 104 weeks
measure: Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks
timeFrame: Baseline through 104 weeks
Locations:
city: Peoria
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Phoenix
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Tucson
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Fresno
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Mission Hills
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Longmont
country: United States
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state: Colorado
city: Waterbury
country: United States
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state: Connecticut
city: Hollywood
country: United States
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state: Florida
city: West Palm Beach
country: United States
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state: Florida
city: Athens
country: United States
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state: Georgia
city: Atlanta
country: United States
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state: Georgia
city: Idaho Falls
country: United States
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state: Idaho
city: Springfield
country: United States
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state: Illinois
city: Topeka
country: United States
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state: Kansas
city: Metairie
country: United States
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state: Louisiana
city: Biddeford
country: United States
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state: Maine
city: Ann Arbor
country: United States
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state: Michigan
city: Southfield
country: United States
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state: Michigan
city: St Clair Shores
country: United States
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state: Michigan
city: St Louis
country: United States
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state: Missouri
city: Billings
country: United States
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state: Montana
city: Las Vegas
country: United States
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state: Nevada
city: Rochester
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Greensboro
country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Winston-Salem
country: United States
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state: North Carolina
city: Corvallis
country: United States
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state: Oregon
city: Charleston
country: United States
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state: South Carolina
city: Dallas
country: United States
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state: Texas
city: Georgetown
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Federal Way
country: United States
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state: Washington
city: Tacoma
country: United States
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state: Washington
city: Calgary
country: Canada
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state: Alberta
city: Winnipeg
country: Canada
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state: Manitoba
city: Oakville
country: Canada
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state: Ontario
city: Sherbrooke
country: Canada
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state: Quebec
city: Corbeil-Essonnes
country: France
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city: La Rochelle
country: France
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city: Mantes La Jolie
country: France
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city: Montpellier
country: France
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city: Narbonne
country: France
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city: Saint Mande
country: France
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city: Strasbourg
country: France
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city: Toul
country: France
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city: Venissieux
country: France
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city: Aschaffenburg
country: Germany
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city: Bad Lauterberg
country: Germany
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city: Bad Staffelstein
country: Germany
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city: Bochum
country: Germany
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city: Essen
country: Germany
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city: Hamburg
country: Germany
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city: Hirschhorn
country: Germany
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city: Mainz
country: Germany
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city: Muenster
country: Germany
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city: Neuwied
country: Germany
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city: Pohlheim
country: Germany
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city: Rotenburg-Fulda
country: Germany
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city: Ahmedabad
country: India
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city: Bangalore
country: India
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city: Ghaziabad
country: India
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city: Kochin
country: India
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city: Pune
country: India
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city: Goyang-Si
country: Korea, Republic of
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city: Incheon
country: Korea, Republic of
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city: Seongnam-Si
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Sungnam-Si
country: Korea, Republic of
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Aguascalientes
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Chihuahua
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Guadalajara
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Monterrey
country: Mexico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gdynia
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lodz
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lublin
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Szczecin
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wroclaw
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Manati
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: San Juan
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Baia Mare
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Cluj-Napoca
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Timisoara
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Arkhangelsk
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Rostov-On-Don
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Saint Petersburg
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Dos Hermanas
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lleida
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malaga
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Palma De Mallorca
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Pozuelo De Alarcon
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Chiayi City
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kaohsiung
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taichung City
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taichung
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Tainan
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Taipei
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Yung-Kang, Tainan
country: Taiwan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_CHAIR
References:
citation: Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.
citation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
citation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
citation: Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.
citation: Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.
citation: Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.