Clinical trial NCT02205528: A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 2a Study With an Open-Label Active Group to Assess the Efficacy and Safety of Once-Daily NNC0090-2746 in Type 2 Diabetic Patients Inadequately Controlled With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 to 70 years, inclusive
* Active diagnosis of T2D for greater than or equal to (\>/=) 3 months
* For females of childbearing potential and males with female partners of childbearing potential, agreement to use highly effective contraceptive measures
* Treated with a stable dose of metformin for at least 8 weeks prior to randomization, and expected to remain at the same stable dose throughout study participation
* Hemoglobin A1c (HbA1c) \>/= 7.2% and less than or equal to (\</=) 10.5%
* Fasting plasma glucose (FPG) less than (\<) 250 milligrams per deciliter (mg/dL)
* C-peptide greater than (\>) 1.5 nanograms per milliliter (ng/mL)
* Body mass index (BMI) \>/= 27 kilograms per meter-squared (kg/m\^2) and \</= 44 kg/m\^2
* Stable weight (+/- 5%) within 12 weeks prior to Screening
* Willing and able to maintain existing diet and exercise habits throughout the study
* Capable of performing SC self-injections on a daily basis during the study

Exclusion Criteria:

* Females who are pregnant or lactating
* History of type 1 diabetes (T1D), diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's Syndrome or acromegaly
* History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
* History of clinically significant diabetic complications such as diabetic proliferative retinopathy or severe diabetic neuropathy (requiring treatment with antidepressants or opioids)
* History of severe hypoglycemia within 6 months prior to Screening
* History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data
* History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding
* History of an eating disorder (e.g., bulimia, anorexia)
* History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to Screening
* Personal or family history of medullary thyroid carcinoma
* History of multiple endocrine neoplasia syndrome type 2
* History of chronic or acute pancreatitis or hemochromatosis
* History of significant cardiovascular disease (such as congestive heart failure New York Heart Association Class II to IV, myocardial infarction within the previous 6 months, coronary disease, or uncontrolled hypertension)
* History of clinically significant renal or liver disease
* History of hypersensitivity or previous intolerance to incretin or glucagon analogues
* Elevations in lipase or amylase levels at Screening \> 1.5 times the upper limit of normal (ULN) and considered clinically significant by the investigator
* Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C antibody test at Screening
* Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Screening, or active enrollment in another investigational medication or device study
* Any condition, disorder, or abnormal laboratory test findings at screening that, in the judgment of the investigator, would interfere with the participant's ability to comply with all study requirements, or would require the administration of a treatment during the study that could potentially affect the interpretation of the study data, or would place the participant at unacceptable risk by his/her participation in the study

Primary outcomes:
measure: Change in HbA1c
timeFrame: Day 1; Week 8
Secondary outcomes:
measure: Change in body weight
timeFrame: Day 1; Week 8; Week 12
measure: Percent change in body weight
timeFrame: Day 1; Week 8; Week 12
measure: Change in fasting plasma glucose (FPG)
timeFrame: Day 1; Week 12
measure: Change in post-prandial plasma glucose level
timeFrame: Day -7; Week 12
measure: Change in post-prandial insulin level
timeFrame: Day -7; Week 12
measure: Change in post-prandial C-peptide level
timeFrame: Day -7; Week 12
measure: Change in beta-cell function
timeFrame: Day 1; Week 12
measure: Incidence of treatment-emergent adverse events
timeFrame: Day 1; Week 18
measure: Change in percent HbA1c
timeFrame: Day 1; Week 12
Other outcomes:
Locations:
city: Chino
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Hawaiian Gardens
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Spring Valley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Sanford
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Evanston
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Oxon Hill
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Berlin
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novo Nordisk Investigational Site
state: New Mexico
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Knoxville
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Manassas
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
citation: Frias JP, Bastyr EJ 3rd, Vignati L, Tschop MH, Schmitt C, Owen K, Christensen RH, DiMarchi RD. The Sustained Effects of a Dual GIP/GLP-1 Receptor Agonist, NNC0090-2746, in Patients with Type 2 Diabetes. Cell Metab. 2017 Aug 1;26(2):343-352.e2. doi: 10.1016/j.cmet.2017.07.011.