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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00611884
First received: January 29, 2008
Last updated: September 22, 2011
Last verified: September 2011
History of Changes

January 29, 2008
September 22, 2011
January 2008
August 2008   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611884 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Plasma glucose profiles [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • 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: No ]
Not Provided
Not Provided
 
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: insulin glargine
    Treat-to-target dose titration scheme, s.c. injection.
  • Drug: metformin
    Tablets, 1500-2000 mg/day
  • Drug: NN1250
    Formulation 1: Treat-to-target dose titration scheme, s.c. injection, once daily
  • Drug: NN1250
    Formulation 2: Treat-to-target dose titration scheme, s.c. injection, once daily
  • Drug: NN1250
    Formulation 1: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
  • Experimental: A
    Interventions:
    • Drug: metformin
    • Drug: NN1250
  • Experimental: B
    Interventions:
    • Drug: metformin
    • Drug: NN1250
  • Experimental: C
    Interventions:
    • Drug: metformin
    • Drug: NN1250
  • Active Comparator: D
    Interventions:
    • Drug: insulin glargine
    • Drug: metformin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   India,   South Africa
 
NCT00611884
NN1250-1836, 2007-002475-13
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Benedikte J. Lertoft, DVM Novo Nordisk
Novo Nordisk
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP