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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01720290
Enrollment
150
Registered
2012-11-02
Start date
2002-07-25
Completion date
2003-02-25
Last updated
2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGrepaglinide

Dose individually adjusted

DRUGmetformin

Dose individually adjusted

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
Change in HbA1c (glycosylated haemoglobin A1c)

Secondary

MeasureTime frame
Fasting blood glucose (FBG)
1-hour post prandial blood glucose (PPBG)
Incidence of hypoglycemic episodes

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026