NCT00909480|CompletedPhase 4Results

Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

EFFICACY

A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

Compare

1 other identifier

NN304-1768

Study Type

interventional

Target

457

Locations

6 countries

Sites

Timeline

RegisteredMay 2009

StartedMay 2009

CompletionJun 2010

Brief Summary

This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Trial Health

On Track

Trial Health Score

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

Enrollment

457

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started May 2009

Geographic Reach

6 countries

88 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

1.1 years study duration

Study Start

First participant enrolled

May 1, 2009

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

September 27, 2011

Completed

Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

May 27, 2009

Results QC Date

June 10, 2011

Last Update Submit

January 30, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c From Baseline
Week 0, Week 26

Secondary Outcomes (13)

Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Week 26
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
Week 26
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Week 26
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
Week 26
Fasting Plasma Glucose (FPG)
Week 26
+8 more secondary outcomes

Study Arms (2)

IDet

EXPERIMENTAL

Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day

Drug: insulin detemir

IGlar

ACTIVE COMPARATOR

Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day

Drug: insulin glargine

Interventions

insulin detemirDRUG

Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

IDet

insulin glargineDRUG

IGlar

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosed with type 2 diabetes for at least 6 months
Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months
Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)
HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)
Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2

You may not qualify if:

Any contraindication to insulin detemir or insulin glargine according to the local labelling
Receipt of any investigational product within 4 weeks
Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)
Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

Contact the study team to confirm eligibility.