Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes | Completed
Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Type 2 Diabetes
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01646320
Primary Trial ID Number
Summary
The purpose of this study is to learn if BMS-512148 (Dapagliflozin) as part of a triple combination therapy can improve (decrease) hemoglobin A1c in patients with type 2 diabetes after 24 weeks of treatment compared to a 2 drug oral antidiabetic therapy. The safety of this treatment will also be studied.
Research Details
  • Prior to randomization, all eligible subjects will receive open-label treatment with Saxagliptin 5mg and Metformin IR during the 16-week open-label treatment period.
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Dapagliflozin, Drug : Placebo matching with Dapagliflozin, Drug : Saxagliptin, Drug : Metformin immediate release (IR)

Study Arm Groups : Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR, Arm 2: Placebo + Saxagliptin + Metformin IR, Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR, Arm 2: Placebo + Saxagliptin + Metformin IR, Arm1: Dapagliflozin (10 mg) + Saxagliptin + Metformin IR, Arm 2: Placebo + Saxagliptin + Metformin IR

Intervention Type
See Interventions above
Primary Outcome Measures
  • Mean change from baseline in Glycosylated hemoglobin (HbA1c); Baseline (Day 1); Mean change from baseline in Glycosylated hemoglobin (HbA1c); Week 24
Secondary Outcome Measures
  • Mean change from baseline in fasting plasma glucose (FPG); Baseline (Day 1) and Week 24; Mean change from baseline in 2-hour post-prandial glucose during a liquid meal tolerance test (2-h MTT); Baseline (Day 1) and Week 24; Mean change from baseline in total body weight; Baseline (Day 1) and Week 24; Percent of subjects achieving a therapeutic glycemic response, defined as a HbA1c < 7.0%; Week 24
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Males and females, ≥ 18 years old, with type 2 diabetes with inadequate glycemic
  • control HbA1c ≥ 7.5% - ≤ 11.5%
  • - Stable dose of Metformin for at least 8 weeks
  • - C-peptide ≥ 1.0 ng/mL
  • - Body Mass Index ≤ 45.0 kg/m2
  • Exclusion Criteria:
  • - Estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1.73m2 or serum creatinine
  • (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • - Aspartate aminotransferase (AST) and /or Alanine aminotransferase (ALT) > 3.0 times
  • the upper limit of normal (ULN)
  • - Serum total bilirubin > 2.5 x ULN
  • - Systolic blood pressure (SBP) ≥ 160 mmHg and/or Diastolic blood pressure (DBP) ≥
  • 100mmHg
  • - Cardiovascular disease within 3 months of the screening visit
  • - Currently unstable or serious cardiovascular, renal, hepatic, hematological,
  • oncological, endocrine, psychiatric, or rheumatic diseases
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Royal Liverpool University Hospital
Liverpool
England
L7 8XP
St. Mary's Hospital
Newport
England
PO30 5TG
Altana Pharma/Nycomed
Chippenham
SN15 1HP
Portsmouth
PO3 6LY
Local Institution
Bedfordshire
Gamlingay
SG19 3JR
London
W6 7HY
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Czech Republic, Mexico, Poland, Puerto Rico, Romania, Russian Federation, United Kingdom
Scientific Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Therapy With Dapagliflozin Added to Saxagliptin in Combination With Metformin Compared to Therapy With Placebo Added to Saxagliptin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin and Saxagliptin
EudraCT Number
Not available for this trial
Funder(s)
  • AstraZeneca
Other Study ID Numbers
MB102-129
Sponsor(s)
Bristol-Myers Squibb
Key Dates

Recruitment Start Date

Sep 2012

Recruitment End Date

Aug 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

18 Jul 2012

Last Updated

03 Sep 2015