Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes

NCT ID: NCT01562561

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

PHASE3

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-01

Study Completion Date

2002-12-20

Brief Summary

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This trial is conducted in Asia and South Africa. The aim of this trial is to compare the efficacy and safety of repaglinide plus insulin NPH (insulin Neutral Protamine Hagedorn) with insulin NPH alone in subjects with type 2 diabetes inadequately controlled on repaglinide.

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 + NPH

Group Type EXPERIMENTAL

repaglinide

Intervention Type DRUG

2 mg at each main meal

insulin NPH

Intervention Type DRUG

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

NPH

Group Type ACTIVE_COMPARATOR

insulin NPH

Intervention Type DRUG

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Interventions

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repaglinide

2 mg at each main meal

Intervention Type DRUG

insulin NPH

Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* HbA1c (glycosylated haemoglobin): 7-13% (both inclusive)
* BMI (body mass index) maximum 35 kg/m\^2
Minimum Eligible Age

18 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

Shatin, New Territories, , Hong Kong

Site Status

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Marikina City, , Philippines

Site Status

Novo Nordisk Investigational Site

Pasig, , Philippines

Site Status

Novo Nordisk Investigational Site

Quezon City, , Philippines

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Brits, North West, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Novo Nordisk Investigational Site

Alberton, , South Africa

Site Status

Novo Nordisk Investigational Site

Tainan City, , Taiwan

Site Status

Countries

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Hong Kong Malaysia Philippines South Africa Taiwan

References

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Panelo A, Wing JR; AGEE-1272 Study Group. Repaglinide/bedtime NPH insulin is comparable to twice-daily NPH insulin. Diabetes Care. 2005 Jul;28(7):1789-90. doi: 10.2337/diacare.28.7.1789. No abstract available.

Reference Type RESULT
PMID: 15983336 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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AGEE-1272

Identifier Type: -

Identifier Source: org_study_id

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