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

NCT ID: NCT00611884

Last Updated: 2017-03-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SIBA (D)

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/day

SIBA (E)

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/day

SIBA (D) M, W, F

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/day

IGlar

Group Type ACTIVE_COMPARATOR

insulin glargine

Intervention Type DRUG

Treat-to-target dose titration scheme, s.c. injection.

metformin

Intervention Type DRUG

Tablets, 1500-2000 mg/day

Interventions

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insulin glargine

Treat-to-target dose titration scheme, s.c. injection.

Intervention Type DRUG

insulin degludec

Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily

Intervention Type DRUG

insulin degludec

Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily

Intervention Type DRUG

insulin degludec

Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly

Intervention Type DRUG

metformin

Tablets, 1500-2000 mg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
* Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
* HbA1c 7.0-11.0 % (both inclusive)
* Body Mass Index (BMI) 23-42 kg/m\^2 \[lb/in\^2 x 703\] (both inclusive)

Exclusion Criteria

* Metformin contraindication according to local practice
* Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
* Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Inglewood, California, United States

Site Status

Novo Nordisk Investigational Site

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

Redlands, California, United States

Site Status

Novo Nordisk Investigational Site

Spring Valley, California, United States

Site Status

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Site Status

Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Springfield, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Greensboro, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Medford, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Simpsonville, South Carolina, United States

Site Status

Novo Nordisk Investigational Site

Kingsport, Tennessee, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

San Antonio, Texas, United States

Site Status

Novo Nordisk Investigational Site

Newport News, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Renton, Washington, United States

Site Status

Novo Nordisk Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Novo Nordisk Investigational Site

Cambridge, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Etobicoke, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Site Status

Novo Nordisk Investigational Site

Hyderabad, Andhra Pradesh, India

Site Status

Novo Nordisk Investigational Site

Kochi, Kerala, India

Site Status

Novo Nordisk Investigational Site

Mumbai, Maharashtra, India

Site Status

Novo Nordisk Investigational Site

Vellore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Countries

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United States Canada India South Africa

References

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Zinman B, Fulcher G, Rao PV, Thomas N, Endahl LA, Johansen T, Lindh R, Lewin A, Rosenstock J, Pinget M, Mathieu C. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet. 2011 Mar 12;377(9769):924-31. doi: 10.1016/S0140-6736(10)62305-7.

Reference Type RESULT
PMID: 21396703 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN1250-1836

Identifier Type: -

Identifier Source: org_study_id

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