Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments exantide with dapagliflozin, exentide, dapagliflozin
Phase phase 3
Sponsor AstraZeneca
Start date September 2014
End date April 2016
Trial size 1375 participants
Trial identifier NCT02229396, 2014-003503-29, D5553C00003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
exantide with dapagliflozin
2 mg weekly suspension injection and 10 mg Dapagliflozin
(Experimental)
exentide
2 mg
(Active Comparator)
dapagliflozin
10 mg once daily Dapagliflozin

Primary Outcomes

Measure
Efficacy of exenatide in terms of change in glycosylated hemoglobin (HbA1c)
time frame: from baseline to Week 28

Secondary Outcomes

Measure
Efficacy of exenatide in terms of change in total body weight
time frame: from Baseline to Week 28
Efficacy of exenatide in terms of change in fasting plasma glucose (FPG) from baseline to Week 28.
time frame: from Baseline to Week 28
Efficacy of exenatide in terms of change in 2-hour postprandial glucose (PPG) after a standardized meal tolerance test
time frame: at Week 28
Efficacy of exenatide in terms of proportion of patients achieving HbA1c <7.0%
time frame: at Week 28
Efficacy of exenatide in terms of proportion of patients achieving weight loss ≥5.0%
time frame: at Week 28
Efficacy of exenatide in terms of change in FPG
time frame: from Baseline to Week 28
Efficacy of exenatide in terms of change in seated systolic Blood Pressure
time frame: from Baseline to Week 28

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.