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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 245
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
Experimental: SIBA (D) Drug: insulin degludec
Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily
Drug: metformin
Tablets, 1500-2000 mg/day
Experimental: SIBA (E) Drug: insulin degludec
Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily
Drug: metformin
Tablets, 1500-2000 mg/day
Experimental: SIBA (D) M, W, F Drug: insulin degludec
Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly
Drug: metformin
Tablets, 1500-2000 mg/day
Active Comparator: IGlar 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 to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 83404-7596
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60616
Novo Nordisk Clinical Trial Call Center
Springfield, Illinois, United States, 62711
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Greensboro, North Carolina, United States, 27408
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, 29681-1538
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
Norfolk, Virginia, United States, 23502
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
Etobicoke, Ontario, Canada, M9R 4E1
India
Vellore, Tamil Nadu, India, 632004
South Africa
Johannesburg, Gauteng, South Africa, 2001
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00611884     History of Changes
Other Study ID Numbers: NN1250-1836 
Study First Received: January 29, 2008
Results First Received: October 16, 2015
Last Updated: October 16, 2015
Health Authority: India: Ministry of Health
South Africa: Medicines Control Council
United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016