Clinical trial NCT01003184: Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes
Official title: Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide once weekly
Byetta
insulin detemir
Levemir
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2009-10-28
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.


Eligibility criteria: Inclusion Criteria:

* Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
* Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
* Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start

Exclusion Criteria:

* Have any contraindication for the OAD that they have been using
* Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
* Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
* Have been treated with drugs that promote weight loss, within 3 months of screening
* Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: insulin, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
* Have previously completed or withdrawn from this study or any other study investigating exenatide QW
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Primary outcomes:
measure: Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
timeFrame: Baseline, Week 26
measure: Change in HbA1c From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Body Weight From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint
timeFrame: Week 26
measure: Percentage of Patients Achieving ≤7.0% at Endpoint
timeFrame: Week 26
measure: Percentage of Patients Achieving ≤6.5% at Endpoint
timeFrame: Week 26
measure: Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).
timeFrame: Baseline, Week 26
measure: Changes in Systolic Blood Pressure From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Diastolic Blood Pressure From Baseline to Week 26.
timeFrame: Baseline, Week 26
measure: Change in Total Cholesterol From Baseline to Endpoint (Week 26).
timeFrame: Baseline, Week 26
measure: Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).
timeFrame: Baseline, Week 26
measure: Change in Triglycerides From Baseline to Endpoint (Week 26).
timeFrame: Baseline, Week 26
measure: Hypoglycemia Rate Per Year
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Research Site
city: Addlestone
country: United Kingdom
facility: Research Site
state: England
city: Bath
country: United Kingdom
facility: Research Site
state: England
city: Birmingham
country: United Kingdom
facility: Research Site
state: England
city: Blackburn
country: United Kingdom
facility: Research Site
state: England
city: Bournemouth
country: United Kingdom
facility: Research Site
state: England
city: Chippenham
country: United Kingdom
facility: Research Site
state: England
city: Derby
country: United Kingdom
facility: Research Site
state: England
city: Exeter
country: United Kingdom
facility: Research Site
state: England
city: High Wycombe
country: United Kingdom
facility: Research Site
state: England
city: Hull
country: United Kingdom
facility: Research Site
state: England
city: Leicester
country: United Kingdom
facility: Research Site
state: England
city: Liverpool
country: United Kingdom
facility: Research Site
state: England
city: London
country: United Kingdom
facility: Research Site
state: England
city: Manchester
country: United Kingdom
facility: Research Site
state: England
city: Merseyside
country: United Kingdom
facility: Research Site
state: England
city: Middlesborough
country: United Kingdom
facility: Research Site
state: England
city: Newcastle
country: United Kingdom
facility: Research Site
state: England
city: Northampton
country: United Kingdom
facility: Research Site
state: England
city: Oldham
country: United Kingdom
facility: Research Site
state: England
city: Plymouth
country: United Kingdom
facility: Research Site
state: England
city: Portsmouth
country: United Kingdom
facility: Research Site
state: England
city: Sheffield
country: United Kingdom
facility: Research Site
state: England
city: Stevenage
country: United Kingdom
facility: Research Site
state: England
city: Suffolk
country: United Kingdom
facility: Research Site
state: England
city: Wakefield
country: United Kingdom
facility: Research Site
state: England
city: Wiltshire
country: United Kingdom
facility: Research Site
state: England
city: Aberdeen
country: United Kingdom
facility: Research Site
state: Scotland
city: Dundee
country: United Kingdom
facility: Research Site
state: Scotland
city: Carmathen
country: United Kingdom
facility: Research Site
state: Wales
city: Swansea
country: United Kingdom
facility: Research Site
state: Wales
city: Wrexham
country: United Kingdom
facility: Research Site
state: Wales
city: Leytonstone
country: United Kingdom
facility: Research Site
city: Livingston
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.