Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy (INITIATE)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00598793
First received: January 11, 2008
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: insulin glargine
Drug: metformin
Drug: pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 28 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postprandial glucose by 8-point SMBG [ Designated as safety issue: No ]
  • Number of subjects achieving HbA1c below 7% [ Designated as safety issue: No ]
  • Number of hypoglycemic episodes and adverse events [ Designated as safety issue: No ]
  • Weight change [ Designated as safety issue: No ]
  • Insulin dose [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: November 2002
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Insulin naive Type 2 diabetes
  • Currently treated with OADs alone or combined with other treatment for at least 3 months
  • BMI below 40 kg/m2 and body weight below 125 kg
  • HbA1c greater than or equal to 8%

Exclusion Criteria:

  • Inability to tolerate metformin or contradictions to its use
  • Pregnant, breastfeeding or intention of becoming pregnant
  • Allergy to any of the trial products
  • Inability or unwillingness to perform SMBG
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598793

  Show 26 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Plamen Kozlovski Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00598793     History of Changes
Other Study ID Numbers: BIASP-2163
Study First Received: January 11, 2008
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014