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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: insulin detemir; Drug: sitagliptin; Drug: metformin; Drug: sulphonylurea

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Niagara Falls, Canada, L2G 5X7
    • Novo Nordisk Investigational Site
  • British Columbia
    • Coquitlam, British Columbia, Canada, V3K 3P4
      • Novo Nordisk Investigational Site
    • New Westminster, British Columbia, Canada, V3L 3W5
      • Novo Nordisk Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Novo Nordisk Investigational Site
  • Ontario
    • Cambridge, Ontario, Canada, N1R 7L6
      • Novo Nordisk Investigational Site
    • Niagara Falls, Ontario, Canada, L2E 7H1
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M3J 1N2
      • Novo Nordisk Investigational Site
    • Toronto, Ontario, Canada, M9W 4L6
      • Novo Nordisk Investigational Site
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 4J6
      • Novo Nordisk Investigational Site
    • St. Romuald, Quebec, Canada, G6W 5M6
      • Novo Nordisk Investigational Site
• Finland
  • Helsinki, Finland, FI-00350
    • Novo Nordisk Investigational Site
  • Loimaa, Finland, FI-32200
    • Novo Nordisk Investigational Site
  • Oulu, Finland, FI-90220
    • Novo Nordisk Investigational Site
  • Pieksämäki, Finland, 76100
    • Novo Nordisk Investigational Site
  • Pori, Finland, FI-28100
    • Novo Nordisk Investigational Site
  • Seinäjoki, Finland, FI-60100
    • Novo Nordisk Investigational Site
• France
  • Brest, France, 29200
    • Novo Nordisk Investigational Site
  • LA ROCHE-sur-YON cedex 9, France, 85295
    • Novo Nordisk Investigational Site
  • Le Creusot, France, 71200
    • Novo Nordisk Investigational Site
  • Lille, France, 59037
    • Novo Nordisk Investigational Site
  • Montigny-les-Metz, France, 57950
    • Novo Nordisk Investigational Site
  • Narbonne, France, 11108
    • Novo Nordisk Investigational Site
  • Roubaix, France, 59100
    • Novo Nordisk Investigational Site
• Hungary
  • Budapest, Hungary, 1083
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, 1125
    • Novo Nordisk Investigational Site
  • Budapest, Hungary, H-1212
    • Novo Nordisk Investigational Site
  • Eger, Hungary, 3300
    • Novo Nordisk Investigational Site
  • Pécs, Hungary, 7623
    • Novo Nordisk Investigational Site
• Korea, Republic of
  • Daegu, Korea, Republic of, 705-717
    • Novo Nordisk Investigational Site
  • Incheon, Korea, Republic of, 400-103
    • Novo Nordisk Investigational Site
  • Seoul, Korea, Republic of, 135-239
    • Novo Nordisk Investigational Site
• Slovakia
  • Bratislava, Slovakia, 851 01
    • Novo Nordisk Investigational Site
  • Bratislava, Slovakia, 831 01
    • Novo Nordisk Investigational Site
  • Kosice, Slovakia, 040 01
    • Novo Nordisk Investigational Site
  • Lucenec, Slovakia, 98401
    • Novo Nordisk Investigational Site
  • Presov, Slovakia, 080 01
    • Novo Nordisk Investigational Site
  • Zilina, Slovakia, 01001
    • Novo Nordisk Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34098
    • Novo Nordisk Investigational Site
  • Istanbul, Turkey, 34390
    • Novo Nordisk Investigational Site
  • Kocaeli, Turkey, 41380
    • Novo Nordisk Investigational Site
• United States
  • Alabama
    • Vestavia, Alabama, United States, 35209
      • Novo Nordisk Investigational Site
  • California
    • Orange, California, United States, 92869
      • Novo Nordisk Investigational Site
    • Santa Monica, California, United States, 90404
      • Novo Nordisk Investigational Site
  • Georgia
    • Dunwoody, Georgia, United States, 30338
      • Novo Nordisk Investigational Site
  • New York
    • West Seneca, New York, United States, 14224
      • Novo Nordisk Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Novo Nordisk Investigational Site
    • Dayton, Ohio, United States, 45439
      • Novo Nordisk Investigational Site
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19401
      • Novo Nordisk Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • Novo Nordisk Investigational Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c (Glycosylated Haemoglobin A1c)	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major 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	Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia	Week 26
Change in BMI (Body Mass Index)		Week 0, Week 26
Change in Body Weight		Week 0, Week 26
FPG (Fasting Plasma Glucose)		Week 26
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
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
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
Self-measured 9-point Plasma Glucose Profile		Week 26

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: November 10, 2008
• First Submitted That Met QC Criteria: November 10, 2008
• First Posted (Estimate): November 11, 2008

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate; Insulin Detemir
• Other Study ID Numbers: NN304-3511; 2008-001050-40 (EudraCT Number)