Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: sitagliptin Drug: metformin Drug: sulphonylurea	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Metformin Metformin hydrochloride Insulin human Insulin detemir Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c (Glycosylated Haemoglobin A1c) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Change in BMI (Body Mass Index) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
Change in Body Weight [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
FPG (Fasting Plasma Glucose) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Hypoglycemic Episodes [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Hypoglycemic Episodes: Day Time [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
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
Hypoglycemic Episodes: Night Time [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]
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
Self-measured 9-point Plasma Glucose Profile [ Time Frame: Week 26 ] [ Designated as safety issue: No ]

Enrollment:	222
Study Start Date:	November 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Comb Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment	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. Drug: sitagliptin The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily. Drug: metformin Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
Active Comparator: Sita Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment	Drug: sitagliptin The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily. Drug: metformin Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial. Drug: 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.

Arms

Assigned Interventions

Experimental: Comb

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

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.

Drug: sitagliptin

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

Drug: metformin

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

Active Comparator: Sita

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

Drug: sitagliptin

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

Drug: metformin

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

Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789191

Locations

United States, California
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92869
Novo Nordisk Clinical Trial Call Center
Santa Monica, California, United States, 90404
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Dunwoody, Georgia, United States, 30338
Novo Nordisk Clinical Trial Call Center
Vestavia, Georgia, United States, 35209
United States, New York
Novo Nordisk Clinical Trial Call Center
West Seneca, New York, United States, 14224
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45245
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Norristown, Pennsylvania, United States, 19401
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37411
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75246
Canada, British Columbia

Coquitlam, British Columbia, Canada, V3K 3P4
Finland

Pieksämäki, Finland, 76100
France

Narbonne, France, 11108
Hungary

Budapest, Hungary, H-1212
Korea, Republic of

Incheon, Korea, Republic of, 400-103
Slovakia

Bratislava, Slovakia, 831 01
Turkey

Izmit, Turkey, 41380

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Tine Møller Jørgensen, M.Sc. Pharm

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00789191 History of Changes
Other Study ID Numbers:	NN304-3511, 2008-001050-40
Study First Received:	November 10, 2008
Results First Received:	November 18, 2010
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration Canada: The Biologics and Genetic Therapies Directorate (BGTD)

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Insulin
Metformin

Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013