Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Keywords

• Type 2 Diabetes Mellitus, Dipeptidyl-Peptidase 4 Inhibitors, Saxagliptin, Metformin, Endocrine System Diseases

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 1,136 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Study arms

• Experimental
  Saxagliptin 5 mg + Metformin (500 mg with titration)

  Saxagliptin 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

  Drug: Saxagliptin 5 mg · Drug: Metformin 500 mg with titration

• Active comparator
  Saxagliptin 5 mg + Placebo

  Saxagliptin 5 mg once daily and Placebo 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

  Drug: Saxagliptin 5 mg · Drug: Placebo 500 mg for metformin (with titration)

• Active comparator
  Metformin (500 mg with titration) + Placebo

  Placebo 5 mg once daily and metformin 500 mg once daily, then titrate. Acarbose will be used as rescue medication as needed.

  Drug: Placebo 5 mg for Saxagliptin · Drug: Metformin 500 mg with titration

Interventions

• DrugSaxagliptin 5 mg

  Tablet, Oral, 5 mg, Once daily in the morning

  Also known as: Onglyza, BMS-477118

• DrugPlacebo 5 mg for Saxagliptin

  Tablet, Oral, 5 mg, Once daily in the morning

• DrugPlacebo 500 mg for metformin (with titration)

  Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

• DrugMetformin 500 mg with titration

  Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.

  Also known as: Glucophage

Primary outcomes

1. Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.

   Time frame: Baseline to Week 24 (prior to rescue)

Secondary outcomes

1. Glycemic Response Defined as HbA1c < 7.0% at Week 24

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c \< 7.0% at the end of 24 weeks of double-blinded treatment.

   Time frame: Week 24 (prior to rescue)

2. Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment.

   Time frame: Baseline to Week 24 prior to rescue

3. Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.

   Time frame: Baseline to Week 24 prior to rescue

4. Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment.

   Time frame: Week 24 (prior to rescue)

5. Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.

   Time frame: Baseline to Week 24 prior to rescue

6. Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase

   To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment.

   Time frame: Baseline to Week 24

Baseline characteristics

Publications

• Dou J, Ma J, Liu J, Wang C, Johnsson E, Yao H, Zhao J, Pan C. Efficacy and safety of saxagliptin in combination with metformin as initial therapy in Chinese patients with type 2 diabetes: Results from the START study, a multicentre, randomized, double-blind, active-controlled, phase 3 trial. Diabetes Obes Metab. 2018 Mar;20(3):590-598. doi: 10.1111/dom.13117. Epub 2017 Oct 26. PubMed 28926170 ↗