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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01720290
• Collaborator: (none)
• Enrollment: 150
• Locations: 3
• Arms: 3
• Actual Duration (Months): 7.1
• Patients Per Site: 50
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Diabetes; Diabetes Mellitus, Type 2	Drug: repaglinide; Drug: metformin; Drug: metformin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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.
• Actual Study Start Date: Jul 25, 2002
• Actual Primary Completion Date: Feb 25, 2003
• Actual Study Completion Date: Feb 25, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c (glycosylated haemoglobin A1c) []

Secondary Outcome Measures

1. Fasting blood glucose (FBG) []

2. 1-hour post prandial blood glucose (PPBG) []

3. Incidence of hypoglycemic episodes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Beijing	Beijing	China	100191
2	Novo Nordisk Investigational Site	Beijing		China	100029
3	Novo Nordisk Investigational Site	Shanghai		China

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01720290
• Other Study ID Numbers: AGEE-3018
• First Posted: Nov 2, 2012
• Last Update Posted: Feb 20, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Repaglinide

Study Results

No Results Posted as of Feb 20, 2017