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Trial record 24 of 10870 for:    Placebo AND once

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

Tracking Information
First Submitted Date  ICMJE August 28, 2014
First Posted Date  ICMJE September 1, 2014
Results First Submitted Date  ICMJE August 18, 2017
Results First Posted Date  ICMJE September 18, 2017
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE September 6, 2014
Actual Primary Completion Date August 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Efficacy of exenatide in terms of change in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline to Week 28 ]
To compare the change from baseline in HbA1c achieved with exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.
Change History Complete list of historical versions of study NCT02229383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Efficacy of exenatide in terms of change in body weight [ Time Frame: baseline to Week 28 ]
    To compare the effect of exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in 2-hour postprandial glucose (PPG) after a standard meal tolerance test [ Time Frame: at Week 28 ]
    To compare the effect of exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of proportion of patients with HbA1c <7.0% [ Time Frame: at Week 28 ]
    To compare the effect of exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in total mean daily insulin dose [ Time Frame: from Baseline to Week 28 ]
    To compare the effect of exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of proportion of patients with HbA1c <7.0% at Week 28 with no weight gain at Week 28 and no severe hypoglycemia [ Time Frame: over 28 weeks ]
    To compare the effect of exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in systolic blood pressure [ Time Frame: at Week 28 ]
    To compare the effect of exenatide once weekly added to titrated basal insulin glargine, with or without metformin, to placebo added to titrated basal insulin glargine, with or without metformin, on changes in glycemic control and anthropometric measures.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 28, 2014)
Incidence, duration, and time course of adverse events (AEs), Clinical laboratory tests, Physical examination & Vital signs [ Time Frame: Baseline to week 28 ]
To evaluate the safety and tolerability of exenatide once weekly added to titrated basal insulin glargine with or without metformin versus placebo added to titrated basal insulin glargine with or without metformin in patients with T2DM.
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Drug: Exenatide
    2 mg weekly suspension injection
  • Drug: Exenatide matching placebo
    Once weekly Placebo injection
Study Arms  ICMJE
  • Experimental: Exenatide
    Exenatide 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
    Intervention: Drug: Exenatide
  • Placebo Comparator: Placebo
    Placebo 2 mg 1 time per week + titrated basal insulin glargine with or without metformin
    Intervention: Drug: Exenatide matching placebo
Publications * Guja C, Frías JP, Somogyi A, Jabbour S, Wang H, Hardy E, Rosenstock J. Effect of exenatide QW or placebo, both added to titrated insulin glargine, in uncontrolled type 2 diabetes: The DURATION-7 randomized study. Diabetes Obes Metab. 2018 Jul;20(7):1602-1614. doi: 10.1111/dom.13266. Epub 2018 Mar 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2017)
464
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
978
Actual Study Completion Date  ICMJE August 29, 2016
Actual Primary Completion Date August 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Poland,   Romania,   Slovakia,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229383
Other Study ID Numbers  ICMJE D5553C00002
2014-003502-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP