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NCT00909480 Clinical Trial

Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— EFFICACY  

Official title:
A 26 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group, Treat-to-target Once Daily Treatment Trial With Insulin Detemir Versus Insulin Glargine, Both in Combination With Metformin in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00909480
Other study ID # NN304-1768
Secondary ID
Status Completed
Phase Phase 4
First received May 27, 2009
Last updated December 17, 2014
Start date May 2009
Est. completion date June 2010

Study information
Verified date December 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaIndia: Ministry of HealthSouth Korea: Korea Food and Drug Administration (KFDA)Thailand: Thai FDA
Study type Interventional

Clinical Trial Summary

This trial is conducted in Asia, South America and the United States of America (USA).

The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).

Recruitment information / eligibility
Status Completed
Enrollment 457
Est. completion date June 2010
Est. primary completion date June 2010
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

- Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months

- Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)

- HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed)

- Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Exclusion Criteria:

- Any contraindication to insulin detemir or insulin glargine according to the local labelling

- Receipt of any investigational product within 4 weeks

- Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids)

- Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product

- Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir
Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued
• insulin glargine
Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued

Locations
Country Name City State
Puerto Rico Novo Nordisk Clinical Trial Call Center Manati
Puerto Rico Novo Nordisk Clinical Trial Call Center Trujillo Alto
United States Novo Nordisk Clinical Trial Call Center Altoona Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Anaheim California
United States Novo Nordisk Clinical Trial Call Center Buckley Michigan
United States Novo Nordisk Clinical Trial Call Center Butte Montana
United States Novo Nordisk Clinical Trial Call Center Charlotte North Carolina
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
United States Novo Nordisk Clinical Trial Call Center Chattanooga Tennessee
United States Novo Nordisk Clinical Trial Call Center Chesterfield Missouri
United States Novo Nordisk Clinical Trial Call Center Cincinnati Ohio
United States Novo Nordisk Clinical Trial Call Center Clarion Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Clilfton New Jersey
United States Novo Nordisk Clinical Trial Call Center Concord California
United States Novo Nordisk Clinical Trial Call Center Corpus Christi Texas
United States Novo Nordisk Clinical Trial Call Center Dallas Texas
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 Escondido California
United States Novo Nordisk Clinical Trial Call Center Fresno California
United States Novo Nordisk Clinical Trial Call Center Gallipolis Ohio
United States Novo Nordisk Clinical Trial Call Center Goodyear Arizona
United States Novo Nordisk Clinical Trial Call Center Greensboro North Carolina
United States Novo Nordisk Clinical Trial Call Center Greer South Carolina
United States Novo Nordisk Clinical Trial Call Center Hollywood Florida
United States Novo Nordisk Clinical Trial Call Center Houston Texas
United States Novo Nordisk Clinical Trial Call Center Hurst Texas
United States Novo Nordisk Clinical Trial Call Center Idaho Falls Idaho
United States Novo Nordisk Clinical Trial Call Center Independence Kansas
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center Jacksonville Florida
United States Novo Nordisk Clinical Trial Call Center Jefferson City Missouri
United States Novo Nordisk Clinical Trial Call Center Lancaster Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Long Beach California
United States Novo Nordisk Clinical Trial Call Center Los Angeles California
United States Novo Nordisk Clinical Trial Call Center Martinsburg West Virginia
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Miami Florida
United States Novo Nordisk Clinical Trial Call Center Milwaukee Wisconsin
United States Novo Nordisk Clinical Trial Call Center Norristown Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Northport New York
United States Novo Nordisk Clinical Trial Call Center Norwalk Connecticut
United States Novo Nordisk Clinical Trial Call Center Ocala Florida
United States Novo Nordisk Clinical Trial Call Center Odessa Texas
United States Novo Nordisk Clinical Trial Call Center Orlando Florida
United States Novo Nordisk Clinical Trial Call Center Philadelphia Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Philadelphia Pennsylvania
United States Novo Nordisk Clinical Trial Call Center Plantation Florida
United States Novo Nordisk Clinical Trial Call Center Ponte Vedra Florida
United States Novo Nordisk Clinical Trial Call Center Portland Maine
United States Novo Nordisk Clinical Trial Call Center Powder Springs Georgia
United States Novo Nordisk Clinical Trial Call Center Redlands California
United States Novo Nordisk Clinical Trial Call Center Renton Washington
United States Novo Nordisk Clinical Trial Call Center Rockville Maryland
United States Novo Nordisk Clinical Trial Call Center Roswell Georgia
United States Novo Nordisk Clinical Trial Call Center San Antonio Texas
United States Novo Nordisk Clinical Trial Call Center Santa Ana California
United States Novo Nordisk Clinical Trial Call Center Searcy Arkansas
United States Novo Nordisk Clinical Trial Call Center Shawnee Mission Kansas
United States Novo Nordisk Clinical Trial Call Center Spartanburg South Carolina
United States Novo Nordisk Clinical Trial Call Center Spring Valley California
United States Novo Nordisk Clinical Trial Call Center St. George Utah
United States Novo Nordisk Clinical Trial Call Center St. Louis Missouri
United States Novo Nordisk Clinical Trial Call Center Staten Island New York
United States Novo Nordisk Clinical Trial Call Center Syracuse New York
United States Novo Nordisk Clinical Trial Call Center Taylors South Carolina
United States Novo Nordisk Clinical Trial Call Center Virginia Beach Virginia
United States Novo Nordisk Clinical Trial Call Center Waltham Massachusetts
United States Novo Nordisk Clinical Trial Call Center Winston Salem North Carolina
United States Novo Nordisk Clinical Trial Call Center Winter Haven Florida

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  India,  Korea, Republic of,  Puerto Rico,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c From Baseline Week 0, Week 26 No
Secondary Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% Week 26 No
Secondary Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. Week 26 No
Secondary Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less Week 26 No
Secondary Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. Week 26 No
Secondary Fasting Plasma Glucose (FPG) Week 26 No
Secondary Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. Week 26 No
Secondary Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. Week 26 No
Secondary Incidence of Hypoglycaemic Episodes During the Trial Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Weeks 0-26 No
Secondary Hypoglycaemic Episodes, Diurnal Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Weeks 0-26 No
Secondary Hypoglycaemic Episodes, Nocturnal Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Weeks 0-26 No
Secondary Hypoglycemic Episodes, Unclassifiable Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. Weeks 0-26 No
Secondary Change in Body Weight From Baseline Week 0, Week 26 No
Secondary Number of Subjects Having the Adverse Event "Incorrect Dose Administered" Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications" Weeks 0-26 No
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