Brief Summary

This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.

Trial Health

On Track

Trial Health Score

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

Enrollment

222

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Nov 2008

Shorter than P25 for phase_3 diabetes

Geographic Reach

8 countries

51 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

9 months study duration

Study Start

First participant enrolled

November 1, 2008

Completed

9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

December 10, 2010

Completed

Last Updated

March 14, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

November 10, 2008

Results QC Date

November 18, 2010

Last Update Submit

February 2, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c (Glycosylated Haemoglobin A1c)
Week 26

Secondary Outcomes (11)

Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Week 26
Change in BMI (Body Mass Index)
Week 0, Week 26
+6 more secondary outcomes

Study Arms (2)

Comb

EXPERIMENTAL

Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment

Drug: insulin detemirDrug: sitagliptinDrug: metformin

Sita

ACTIVE COMPARATOR

Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment

Drug: sitagliptinDrug: metforminDrug: sulphonylurea

Interventions

insulin detemirDRUG

The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.

Comb

sitagliptinDRUG

The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.

CombSita

metforminDRUG

Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.

CombSita

sulphonylureaDRUG

Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.

Sita

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 before trial start
Treatment with at least 1000 mg metformin per day for at least 3 months
Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
DPP-4 (dipeptidyl peptidase-4) inhibitor naive
HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
Able and willing to take one subcutaneous injection every day
Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements

You may not qualify if:

Known or suspected allergy or intolerance to any of the trial products or related products
Severe hypertension
Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
Cardiac disease, within the last 12 months
Impaired hepatic function
Impaired renal function
Proliferative retinopathy or macular oedema requiring acute treatment
Female of childbearing potential
Known or suspected abuse of alcohol, narcotics or illicit substances

Contact the study team to confirm eligibility.