NCT01562561|CompletedPhase 3

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

Multi-centre, Multinational, Open-labelled, Randomised, Parallel, Controlled Trial in Type 2 Diabetic Subjects Inadequately Controlled on Repaglinide, to Compare the Efficacy and Safety of Repaglinide Combined With Bedtime NPH Insulin Versus Twice Daily NPH Insulin

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

AGEE-1272

Study Type

interventional

Target

213

Locations

5 countries

Sites

Timeline

RegisteredMar 2012

StartedJun 2001

CompletionDec 2002

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

213

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Jun 2001

Typical duration for phase_3 diabetes

Geographic Reach

5 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

June 1, 2001

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2002

Completed

9.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed

Last Updated

February 20, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

March 22, 2012

Last Update Submit

February 17, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (glycosylated haemoglobin)
Week 0 (visit 5); week 26

Secondary Outcomes (4)

FPG (fasting plasma glucose)
Week 0 (visit 5); week 26
7-point blood glucose profile
Week 0 (visit 5); week 26
Hypoglycaemic episodes
Week 0 (visit 5); week 26
Adverse events
Week 0 (Visit 5); week 26

Study Arms (2)

Rep + NPH

EXPERIMENTAL

Drug: repaglinideDrug: insulin NPH

NPH

ACTIVE COMPARATOR

Drug: insulin NPH

Interventions

repaglinideDRUG

2 mg at each main meal

Rep + NPH

insulin NPHDRUG

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

NPHRep + NPH

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.