Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes - Full Text View

Purpose

This trial is conducted in Africa, Asia and North America.

The aim of the trial is to compare two NN1250 formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glargine Drug: metformin Drug: NN1250	Phase II

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Safety and Efficacy Comparison of Two NN1250 Formulations and Insulin Glargine All in Combination With Metformin in Insulin Naive Subjects With Type 2 Diabetes, Measured by HbA1c After 16 Weeks of Treatment

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Frequency and severity of adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Laboratory safety parameters [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Physical examination and vital signs [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	236
Study Start Date:	January 2008
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: metformin Tablets, 1500-2000 mg/day Drug: NN1250 Formulation 1: Treat-to-target dose titration scheme, s.c. injection, once daily
B: Experimental	Drug: metformin Tablets, 1500-2000 mg/day Drug: NN1250 Formulation 2: Treat-to-target dose titration scheme, s.c. injection, once daily
C: Experimental	Drug: metformin Tablets, 1500-2000 mg/day Drug: NN1250 Formulation 1: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
D: Active Comparator	Drug: insulin glargine Treat-to-target dose titration scheme, s.c. injection. Drug: metformin Tablets, 1500-2000 mg/day

Eligibility

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

Criteria

Inclusion Criteria:

Insulin naive type 2 subjects for at least 3 months
Treatment with a stable dosing of maximally tolerated dose or at least half maximally allowed dose of one or two OADs for at least 2 months
HbA1c 7.0-11.0% (both inclusive)
Body mass index (BMI) 25-42 kg/m2 (both inclusive)

Exclusion Criteria:

Metformin contraindication according to local practice
Treatment with thiazolidinedione (TZD) within the last 3 months prior to screening
Any systemic treatment with products which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) 3 months prior to randomisation
Any disease or condition which according to the investigator would interfere with the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611884

Locations


United States, California
	Novo Nordisk Clinical Trial Call Center
	Los Angeles, California, United States, 90057
	Novo Nordisk Clinical Trial Call Center
	Redlands, California, United States, 92374
	Novo Nordisk Clinical Trial Call Center
	Spring Valley, California, United States, 91978

United States, Florida
	Novo Nordisk Clinical Trial Call Center
	Jacksonville, Florida, United States, 32204

United States, Idaho
	Novo Nordisk Clinical Trial Call Center
	Idaho Falls, Idaho, United States, 83404-7542

United States, Illinois
	Novo Nordisk Clinical Trial Call Center
	Chicago, Illinois, United States, 60607

United States, North Carolina
	Novo Nordisk Clinical Trial Call Center
	Greensboro, North Carolina, United States, 27401-1211

United States, Oregon
	Novo Nordisk Clinical Trial Call Center
	Medford, Oregon, United States, 97504

United States, South Carolina
	Novo Nordisk Clinical Trial Call Center
	Simpsonville, South Carolina, United States, 29681-3237

United States, Tennessee
	Novo Nordisk Clinical Trial Call Center
	Kingsport, Tennessee, United States, 37660

United States, Texas
	Novo Nordisk Clinical Trial Call Center
	Dallas, Texas, United States, 75230
	Novo Nordisk Clinical Trial Call Center
	San Antonio, Texas, United States, 78229

United States, Virginia
	Novo Nordisk Clinical Trial Call Center
	Virginia Beach, Virginia, United States, 23462

United States, Washington
	Novo Nordisk Clinical Trial Call Center
	Renton, Washington, United States, 98057

United States, Wisconsin
	Novo Nordisk Clinical Trial Call Center
	Milwaukee, Wisconsin, United States, 53209

Canada, Ontario

	Cambridge, Ontario, Canada, N1R 7L6

	Toronto, Ontario, Canada, M5T 3L9

	Etobicoke, Ontario, Canada, M9R 4E1

India, Tamilnadu

	Vellore, Tamilnadu, India, 632004

South Africa, Gauteng

	Johannesburg, Gauteng, South Africa, 2001

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Benedikte J. Lertoft, DVM	Novo Nordisk A/S

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN1250-1836, EudraCT No: 2007-002475-13
First Received:	January 29, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00611884
Health Authority:	India: Ministry of Health; South Africa: Medicines Control Council; United States: Institutional Review Board; Canada: The Biologics and Genetic Therapies Directorate (BGTD)