Efficacy and Safety of Repaglinide and Metformin Combination Therapy in Type 2 Diabetes Failing on Oral Anti-diabetic Drugs

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00491725
First received: June 25, 2007
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

This trial is conducted in Asia. The aim of this trial is to evaluate the efficacy and safety of repaglinide and metformin combination therapy in Chinese subjects with type 2 diabetes inadequately controlled with OAD (oral anti-diabetic drugs).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre, Single Armed, Open Labelled Trial to Study the Efficacy and Safety Profile of Repaglinide & Metformin Combination Therapy in Chinese Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 18 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post Prandial Plasma Glucose [ Designated as safety issue: No ]
  • Fasting Plasma Glucose (FPG) [ Designated as safety issue: No ]
  • Safety profile [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: September 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 weeks
  • HbA1c: 8.0-10.0%
  • Current treatment with OAD on monotheray or OAD on combination therapy
  • Body mass index (BMI): 21.0-35.0 kg/m2

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products
  • Recurrent major hypoglycaemia as judged by the Investigator
  • Uncontrolled hypertension
  • Any other significant condition or concomitant disease such as endocrine, cardiac, neurological, malignant or other pancreatic disease as judged by the Investigator
  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: NCT00491725

Locations
China, Beijing
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: JIN Pingping, Bsc Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00491725     History of Changes
Other Study ID Numbers: AGEE-1655
Study First Received: June 25, 2007
Last Updated: January 23, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Repaglinide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014