Clinical trial NCT00909480: Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-05-28
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c From Baseline
timeFrame: Week 0, Week 26
Secondary outcomes:
measure: Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
timeFrame: Week 26
measure: Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
timeFrame: Week 26
measure: Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
timeFrame: Week 26
measure: Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
timeFrame: Week 26
measure: Fasting Plasma Glucose (FPG)
timeFrame: Week 26
measure: Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
timeFrame: Week 26
measure: Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
timeFrame: Week 26
measure: Incidence of Hypoglycaemic Episodes During the Trial
timeFrame: Weeks 0-26
measure: Hypoglycaemic Episodes, Diurnal
timeFrame: Weeks 0-26
measure: Hypoglycaemic Episodes, Nocturnal
timeFrame: Weeks 0-26
measure: Hypoglycemic Episodes, Unclassifiable
timeFrame: Weeks 0-26
measure: Change in Body Weight From Baseline
timeFrame: Week 0, Week 26
measure: Number of Subjects Having the Adverse Event "Incorrect Dose Administered"
timeFrame: Weeks 0-26
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Searcy
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Concord
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Escondido
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Redlands
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Santa Ana
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Spring Valley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Norwalk
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Hollywood
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ocala
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ponte Vedra
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Powder Springs
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Independence
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Maine
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Waltham
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Buckley
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Butte
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Clilfton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Northport
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Staten Island
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Syracuse
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cayahoga Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Gallipolis
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Altoona
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Clarion
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Taylors
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Hurst
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Odessa
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: St. George
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Virginia Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Martinsburg
country: United States
facility: Novo Nordisk Investigational Site
state: West Virginia
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Capital Federal
country: Argentina
facility: Novo Nordisk Investigational Site
city: Mar del Plata
country: Argentina
facility: Novo Nordisk Investigational Site
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Chennai
country: India
facility: Novo Nordisk Investigational Site
state: Tamil Nadu
city: Thriruvananthapuram
country: India
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Trujillo Alto
country: Puerto Rico
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Pathumthani
country: Thailand
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):729-36. doi: 10.1111/dom.12083. Epub 2013 Mar 13.