Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01720290
First received: October 31, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3-month, Open-label, Randomized, Multi-center Study of Repaglinide in Combination With Metformin as Compared to Metformin or Repaglinide Given as Monotherapy for the Treatment of Type 2 Diabetes.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in HbA1c (glycosylated haemoglobin A1c) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting blood glucose (FBG) [ Designated as safety issue: No ]
  • 1-hour post prandial blood glucose (PPBG) [ Designated as safety issue: No ]
  • Incidence of hypoglycemic episodes [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2002
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rep Drug: repaglinide
Dose individually adjusted
Active Comparator: Met Drug: metformin
Dose individually adjusted
Active Comparator: Rep + met Drug: repaglinide
Dose individually adjusted
Drug: metformin
Dose at 1000 mg/day

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)
  • Body Mass Index (BMI) of 21-35 kg/m^2
  • HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion Criteria:

  • Treatment with insulin within the last 3 months preceding the trial
  • Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)
  • Participation in any other clinical trial within 30 days of screening
  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: NCT01720290

Locations
China
Beijing, China, 100029
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Cheng Yuwei Novo Nordisk (China) Pharmaceuticals Co., Ltd
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01720290     History of Changes
Other Study ID Numbers: AGEE-3018
Study First Received: October 31, 2012
Last Updated: October 31, 2012
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on August 01, 2014