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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
insulin detemir
sitagliptin
metformin
sulphonylurea
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Comb

Sita

Arm Description

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

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

Outcomes

Primary Outcome Measures

HbA1c (Glycosylated Haemoglobin A1c)

Secondary Outcome Measures

Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Change in BMI (Body Mass Index)
Change in Body Weight
FPG (Fasting Plasma Glucose)
Hypoglycemic Episodes
Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
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
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
Self-measured 9-point Plasma Glucose Profile

Full Information

First Posted
November 10, 2008
Last Updated
February 2, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00789191
Brief Title
Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes
Official Title
Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comb
Arm Type
Experimental
Arm Description
Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
Arm Title
Sita
Arm Type
Active Comparator
Arm Description
Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sitagliptin
Intervention Description
The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
Intervention Type
Drug
Intervention Name(s)
sulphonylurea
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c (Glycosylated Haemoglobin A1c)
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Time Frame
Week 26
Title
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Description
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Time Frame
Week 26
Title
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Time Frame
Week 26
Title
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Description
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Time Frame
Week 26
Title
Change in BMI (Body Mass Index)
Time Frame
Week 0, Week 26
Title
Change in Body Weight
Time Frame
Week 0, Week 26
Title
FPG (Fasting Plasma Glucose)
Time Frame
Week 26
Title
Hypoglycemic Episodes
Description
Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Time Frame
Weeks 0-26
Title
Hypoglycemic Episodes: Day Time
Description
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
Time Frame
Weeks 0-26
Title
Hypoglycemic Episodes: Night Time
Description
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
Time Frame
Weeks 0-26
Title
Self-measured 9-point Plasma Glucose Profile
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Vestavia
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E 7H1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4J6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
St. Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Niagara Falls
ZIP/Postal Code
L2G 5X7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
FI-00350
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Loimaa
ZIP/Postal Code
FI-32200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
FI-90220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Pieksämäki
ZIP/Postal Code
76100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Pori
ZIP/Postal Code
FI-28100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Seinäjoki
ZIP/Postal Code
FI-60100
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
LA ROCHE-sur-YON cedex 9
ZIP/Postal Code
85295
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Montigny-les-Metz
ZIP/Postal Code
57950
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Narbonne
ZIP/Postal Code
11108
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1212
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Incheon
ZIP/Postal Code
400-103
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
135-239
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
831 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Lucenec
ZIP/Postal Code
98401
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21205123
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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