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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

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ClinicalTrials.gov Identifier: NCT02229383
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : September 18, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added to titrated basal insulin glargine with or without metformin to placebo added to titrated basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the 28-week treatment period.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Exenatide Drug: Exenatide matching placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 6, 2014
Actual Primary Completion Date : August 29, 2016
Actual Study Completion Date : August 29, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide
Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
 Drug: Exenatide
2 mg weekly suspension injection
Placebo Comparator: Placebo
Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
 Drug: Exenatide matching placebo
Once weekly Placebo injection


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.


Secondary Outcome Measures :
  1. Change in Body Weight From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.

  2. Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT) [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.

  3. Percentage of Participants Achieving HbA1c <7.0% at Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the percentage of participants achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.

  4. Change From Baseline to Week 28 in Daily Insulin Dose [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.

  5. 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 ]
    To compare the percentage of participants achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.

  6. Change in Seated Systolic Blood Pressure From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229383


Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02229383    
Other Study ID Numbers: D5553C00002
2014-003502-33 ( EudraCT Number )
First Posted: September 1, 2014    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: January 8, 2019
Last Verified: December 2018
Keywords provided by AstraZeneca:
Diabetes Mellitus
Exenatide
Diabetes drug
Treatment efficacy
 Placebo
Metabolism
Cardiovascilar metabolic
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
 Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists