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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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Exantide with Dapagliflozin Drug: Exentide Drug: Dapagliflozin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 695 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 4, 2014
Actual Primary Completion Date : April 26, 2016
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Drug: Exantide with Dapagliflozin
2 mg weekly suspension injection and 10 mg Dapagliflozin
Experimental: Exenatide Once Weekly 2 mg Alone Drug: Exentide
2 mg
Active Comparator: Dapagliflozin Once Daily 10 mg Alone Drug: Dapagliflozin
10 mg once daily Dapagliflozin


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 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.


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 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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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 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.
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): NCT02229396


Locations
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Sponsors and Collaborators
AstraZeneca
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02229396    
Other Study ID Numbers: D5553C00003
2014-003503-29 ( EudraCT Number )
First Posted: September 1, 2014    Key Record Dates
Results First Posted: September 8, 2017
Last Update Posted: December 31, 2018
Last Verified: December 2018
Keywords provided by AstraZeneca:
Diabetes Mellitus
Exenatide
Dapagliflozin
Diabetes medication
 Treatment efficacy
Placebo
Metabolism
Cardiovascular metabolic
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dapagliflozin
 Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs