Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229396
Recruitment Status : Completed
First Posted : September 1, 2014
Results First Posted : September 8, 2017
Last Update Posted : December 31, 2018
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 9, 2017
Results First Posted Date  ICMJE September 8, 2017
Last Update Posted Date December 31, 2018
Actual Study Start Date  ICMJE September 4, 2014
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
Change in HbA1c From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
Efficacy of exenatide in terms of change in glycosylated hemoglobin (HbA1c) [ Time Frame: from baseline to Week 28 ]
To compare the change from baseline in HbA1c at 28 weeks between EQW 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2017)
  • Change in Body Weight From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
  • Change in Fasting Plasma Glucose From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
  • Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
  • Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
  • Change in Fasting Plasma Glucose From Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
    To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
  • Percentage of Patients Achieving HbA1c <7% at Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
  • Change in Systolic Blood Pressure From Baseline to Week 28 [ Time Frame: Baseline to Week 28 ]
    To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • Efficacy of exenatide in terms of change in total body weight [ Time Frame: from Baseline to Week 28 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in fasting plasma glucose (FPG) from baseline to Week 28. [ Time Frame: from Baseline to Week 28 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in 2-hour postprandial glucose (PPG) after a standardized meal tolerance test [ Time Frame: at Week 28 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of proportion of patients achieving HbA1c <7.0% [ Time Frame: at Week 28 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of proportion of patients achieving weight loss ≥5.0% [ Time Frame: at Week 28 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in FPG [ Time Frame: from Baseline to Week 2 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, on changes in glycemic control and anthropometric measures.
  • Efficacy of exenatide in terms of change in seated systolic Blood Pressure [ Time Frame: from Baseline to Week 28 ]
    To compare the effect of EQW + dapagliflozin to EQW + placebo and/or to dapagliflozin + placebo, 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 AEs, Clinical laboratory tests, Physical examination & Vital signs. [ Time Frame: Baseline to 28 weeks ]
To evaluate the safety and tolerability of simultaneous administration of EQW and dapagliflozin 10 mg QD compared to EQW 2 mg alone and dapagliflozin 10 mg QD.
 
Descriptive Information
Brief Title  ICMJE Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Official Title  ICMJE A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study With a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin
Brief Summary Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter, Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD) compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes who have inadequate glycemic control on metformin.
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: Exantide with Dapagliflozin
    2 mg weekly suspension injection and 10 mg Dapagliflozin
  • Drug: Exentide
    2 mg
  • Drug: Dapagliflozin
    10 mg once daily Dapagliflozin
Study Arms  ICMJE
  • Experimental: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg
    Intervention: Drug: Exantide with Dapagliflozin
  • Experimental: Exenatide Once Weekly 2 mg Alone
    Intervention: Drug: Exentide
  • Active Comparator: Dapagliflozin Once Daily 10 mg Alone
    Intervention: Drug: Dapagliflozin
Publications *

*   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: July 20, 2017)
695
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
1100
Actual Study Completion Date  ICMJE December 28, 2017
Actual Primary Completion Date April 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Has a diagnosis of T2DM.
  • Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
  • Treated with a stable dose of metformin ≥1500 mg/day for at least 2 months prior to Screening.

Exclusion criteria

  • FPG ≥280 mg/dL (15.6 mmol/L).
  • Serum calcitonin concentration ≥40 pg/mL (≥40 ng/L) at Visit 1 (Screening)
  • Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator.
  • Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4.Patients with clinically significant abnormal free T4 values will be excluded.
  • Known active proliferative retinopathy.
  • History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations ≥500 mg/dL (≥5.65 mmol/L) at Visit 1
  • History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
  • History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
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 NCT02229396
Other Study ID Numbers  ICMJE D5553C00003
2014-003503-29 ( 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