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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01006590
First received: October 31, 2009
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Saxagliptin
Drug: Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<7.0% [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below 7.0 percent

  • Proportion of Patients Achieving a Therapeutic Response at Week 24 Defined as HbA1c<=6.5% [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Proportion, percentage of patients in each treatment group, achieving therapeutic response, HbA1c below or equal to 6.5 percent

  • Change From Baseline to Week 24 in Fasting Plasma Glucose [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 24 in Fasting Insulin [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 24 in Beta-cell Function as Measured by Homeostasis Model Assessment-2-beta [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 286
Study Start Date: October 2009
Study Completion Date: December 2010
Arms Assigned Interventions
Experimental: 1
Saxagliptin 5 mg
 Drug: Saxagliptin
5 mg, oral tablet, once daily
Other Name: Onglyza
Active Comparator: 2
Metformin 500 -1000 mg
 Drug: Metformin
500 mg, oral tablet, 1 or 2 additional tablets per day added to background therapy
Other Name: Metformin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006590

  Show 50 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01006590     History of Changes
Other Study ID Numbers: D1680L00003
Study First Received: October 31, 2009
Results First Received: November 30, 2011
Last Updated: January 16, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: CPP Comité de Protection des Personnes = Ethics Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices (Bfarm)
Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
Turkey: Regional Ethics Committee
Turkey: Ministry of Health
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus
Saxagliptin
Randomised
Double-blind

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013