Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02229383
• Date of registration: 28/08/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
• Scientific title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Once Weekly Exenatide Therapy Added to Titrated Basal Insulin Glargine Compared to Placebo Added to Titrated Basal Insulin Glargine in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine With or Without Metformin
• Date of first enrolment: September 6, 2014
• Target sample size: 464
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02229383
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Hungary, Poland, Romania, Slovakia, South Africa, United States

Key inclusion & exclusion criteria

Inclusion criteria:

- Has a diagnosis of Type 2 Diabetes Mellitus (T2DM)

- Has HbA1c of 7.5% to 12.0%, inclusive, at Visit 1 (Screening).

- Has fasting plasma glucose (FPG) concentration <280 mg/dL (15.6 mmol/L) at Visit 1
(Screening)

- Treated with basal insulin glargine at a dose of =20 units/day once daily for at least
6 weeks prior to Screening, in combination with diet and exercise alone or in
combination with:

1. a stable dose of metformin (=1500 mg/day) for at least 8 weeks prior to Visit 1

2. a stable dose of metformin (=1500 mg/day) for at least 8 weeks prior to Visit 1
(Screening) and a stable dose of sulfonylurea for at least 8 weeks prior to the
Screening visit

Exclusion criteria:

- Serum calcitonin concentration =40 pg/mL (=40 ng/L) at Visit 1 (Screening)

- History of, or currently have, acute or chronic pancreatitis, or have triglyceride
concentrations =500 mg/dL (=5.65 mmol/L) at Visit 1

- Positive serological test for hepatitis B or hepatitis C



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Drug: Exenatide matching placebo

Drug: Exenatide

Primary Outcome(s)

Change in HbA1c From Baseline to Week 28 [Time Frame: Baseline to Week 28]

Secondary Outcome(s)

Change From Baseline to Week 28 in Daily Insulin Dose [Time Frame: Baseline to Week 28]

Change in Body Weight From Baseline to Week 28 [Time Frame: Baseline to Week 28]

Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT) [Time Frame: Baseline to Week 28]

Percentage of Participants Achieving HbA1c <7.0% at Week 28 [Time Frame: Baseline to Week 28]

Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks [Time Frame: Baseline to Week 28]

Change in Seated Systolic Blood Pressure From Baseline to Week 28 [Time Frame: Baseline to Week 28]

Secondary ID(s)

2014-003502-33

D5553C00002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02229383