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Completed

NCT Number: NCT01606007

Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Coquitlam, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
  • Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
  • Body mass index (BMI) ≤ 45.0kg/m2

Exclusion criteria

  • Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
  • Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
  • Hepatic disease
  • Cardiovascular disease within 3 months

Treatment and study plan

Saxagliptin

Drug

Tablets, Oral, 5mg , Once daily, 24 weeks

Other names: Onglyza

Metformin XR

Drug

Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks

Other names: Glucophage XR

Dapagliflozin

Drug

Tablets, Oral, 10mg , Once daily, 24 weeks

Other names: BMS-512148

Placebo matching with Dapagliflozin

Drug

Tablets, Oral, 0mg, Once daily, 24 weeks

Placebo matching with Saxagliptin

Drug

Tablets, Oral, 0mg, Once daily, 24 weeks

Primary outcomes

  1. Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24

    Time frame: Baseline (Week 0) and at Week 24

    HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.

Secondary outcomes

  1. Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])

    Time frame: Baseline (Week 0) and at Week 24

    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.

  2. Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline (Week 0) and at Week 24

    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.

  3. Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])

    Time frame: At Week 24

    Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.

  4. Adjusted Mean Change From Baseline in Body Weight at Week 24

    Time frame: Baseline (Week 0) and at Week 24

    Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 25, 2012
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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