Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789191
• Other study ID #: NN304-3511
• Secondary ID: 2008-001050-40
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2008
• Last updated: June 26, 2012
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2012
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: The Biologics and Genetic Therapies Directorate (BGTD)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
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.
• sitagliptin
The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
• metformin
Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
• sulphonylurea
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.

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Chattanooga	Tennessee
United States	Novo Nordisk Clinical Trial Call Center	Cincinnati	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Dallas	Texas
United States	Novo Nordisk Clinical Trial Call Center	Dayton	Ohio
United States	Novo Nordisk Clinical Trial Call Center	Dunwoody	Georgia
United States	Novo Nordisk Clinical Trial Call Center	Norristown	Pennsylvania
United States	Novo Nordisk Clinical Trial Call Center	Orange	California
United States	Novo Nordisk Clinical Trial Call Center	Santa Monica	California
United States	Novo Nordisk Clinical Trial Call Center	Vestavia	Georgia
United States	Novo Nordisk Clinical Trial Call Center	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Hungary,  Korea, Republic of,  Slovakia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c (Glycosylated Haemoglobin A1c)		Week 26	No
Secondary	Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%		Week 26	No
Secondary	Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia	Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia	Week 26	No
Secondary	Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%		Week 26	No
Secondary	Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia	Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia	Week 26	No
Secondary	Change in BMI (Body Mass Index)		Week 0, Week 26	No
Secondary	Change in Body Weight		Week 0, Week 26	No
Secondary	FPG (Fasting Plasma Glucose)		Week 26	No
Secondary	Hypoglycemic Episodes	Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG = 3.1 mmol/L	Weeks 0-26	No
Secondary	Hypoglycemic Episodes: Day Time	Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG = 3.1 mmol/L	Weeks 0-26	No
Secondary	Hypoglycemic Episodes: Night Time	Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG = 3.1 mmol/L	Weeks 0-26	No
Secondary	Self-measured 9-point Plasma Glucose Profile		Week 26	No

External Links

•   Clinical Trials at Novo Nordisk