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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014