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

NCT ID: NCT01720290

Last Updated: 2017-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-25

Study Completion Date

2003-02-25

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rep

Group Type EXPERIMENTAL

repaglinide

Intervention Type DRUG

Dose individually adjusted

Met

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

Dose individually adjusted

Rep + met

Group Type ACTIVE_COMPARATOR

repaglinide

Intervention Type DRUG

Dose individually adjusted

metformin

Intervention Type DRUG

Dose at 1000 mg/day

Interventions

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repaglinide

Dose individually adjusted

Intervention Type DRUG

metformin

Dose individually adjusted

Intervention Type DRUG

metformin

Dose at 1000 mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Site Status

Novo Nordisk Investigational Site

Beijing, , China

Site Status

Novo Nordisk Investigational Site

Shanghai, , China

Site Status

Countries

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China

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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AGEE-3018

Identifier Type: -

Identifier Source: org_study_id

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