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 A/S
ClinicalTrials.gov Identifier:
NCT00611884
First received: January 29, 2008
Last updated: October 16, 2015
Last verified: October 2015

January 29, 2008
October 16, 2015
January 2008
August 2008   (final data collection date for primary outcome measure)
Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
Change from baseline in HbA1c after 16 weeks of treatment
HbA1c [ Time Frame: After 16 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00611884 on ClinicalTrials.gov Archive Site
  • Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.
  • Rate of Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
    Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
  • Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
    Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).
  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
  • Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [ Time Frame: Week -4, Week 16 ] [ Designated as safety issue: No ]
    Mean values at Week -4 and at Week 16
  • Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [ Time Frame: Week -4, Week 16 ] [ Designated as safety issue: No ]
    Mean values at Week -4 and at Week 16
  • Laboratory Safety Parameters (Biochemistry): Serum Creatinine [ Time Frame: Week -4, Week 16 ] [ Designated as safety issue: No ]
    Mean values at Week -4 and at Week 16
  • Vital Signs: Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Mean values at baseline (Week 0) and at Week 16
  • Vital Signs: Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Mean values at baseline (Week 0) and at Week 16
  • Vital Signs: Pulse [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Mean values at baseline (Week 0) and at Week 16
  • Physical Examination [ Time Frame: Week -4, Week 0, Week 8, Week 16 ] [ Designated as safety issue: No ]
    Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
  • 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
A 16 Week Randomised, Open-labelled, Four-armed, Treat-to-target, Parallel-group Trial Comparing SIBA D Once Daily, SIBA E Once Daily, SIBA D Monday, Wednesday and Friday and Insulin Glargine Once Daily, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: insulin glargine
    Treat-to-target dose titration scheme, s.c. injection.
  • Drug: insulin degludec
    Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
  • Drug: insulin degludec
    Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
  • Drug: insulin degludec
    Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
  • Drug: metformin
    Tablets, 1500-2000 mg/day
  • Experimental: SIBA (D)
    Interventions:
    • Drug: insulin degludec
    • Drug: metformin
  • Experimental: SIBA (E)
    Interventions:
    • Drug: insulin degludec
    • Drug: metformin
  • Experimental: SIBA (D) M, W, F
    Interventions:
    • Drug: insulin degludec
    • Drug: metformin
  • Active Comparator: IGlar
    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. doi: 10.1016/S0140-6736(10)62305-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
August 2008
August 2008   (final data collection date for primary outcome measure)

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
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
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
October 2015

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