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Completed

NCT Number: NCT01006590

Efficacy and Tolerability of Saxagliptin add-on Compared to Uptitration of Metformin in Patients With Type 2 Diabetes

The study will evaluate the efficacy and tolerability of saxagliptin compared to uptitration of metformin in patients with type 2 diabetes who have inadequate glycaemic control on a submaximal dose of metformin.

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Key information

Conditions

Type 2 Diabetes Mellitus 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 4

Primary location

Research Site, Brussels (woluwe-st-lambert), Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of signed informed consent
  • Established clinical diagnosis of type 2 diabetes. Treatment with a stable dose of metformin monotherapy (1500-1700 mg/day) for at least 8 weeks prior to visit 1.
  • HbA1c ≥7.0% and ≤10.0%

Exclusion criteria

  • Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma.
  • Renal impairment as defined by a creatinine clearance <60 mL/min/1.73 m2
  • Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study

Treatment and study plan

Saxagliptin

Drug

5 mg, oral tablet, once daily

Other names: Onglyza

metformin

Drug

500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy

Primary outcomes

  1. Absolute Change From Baseline in HbA1c at Week 24

    Time frame: Baseline and 24 weeks

Secondary outcomes

  1. Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0%

    Time frame: 24 Weeks

    Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent

  2. Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5%

    Time frame: 24 Weeks

    Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent

  3. Change From Baseline to Week 24 in Fasting Plasma Glucose

    Time frame: Baseline and 24 weeks

  4. Change From Baseline to Week 24 in Fasting Insulin

    Time frame: Baseline and 24 weeks

  5. Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta

    Time frame: Baseline and 24 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-On Compared to Uptitration of Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

Acronym: PROMPT

Important dates

Study start
2009
Study completion
2010
First posted
Nov 3, 2009
Registry last updated
Jan 19, 2012

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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