Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00660374
First received: February 28, 2008
Last updated: June 15, 2012
Last verified: May 2012
  Purpose

This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin NPH
Drug: EX1000
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: Assessment of Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fructosamine [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • FPG [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
  • 4-point SMPG 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 (including injection site reactions) [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
  • Laboratory safety parameters (haematology, biochemistry and lipids) [ 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 ]
  • HbA1c [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: insulin NPH
"Soft-treat-to-target" dose titration scheme, injection s.c.
Other Name: Insulatard® 100 IU/mL
Experimental: B Drug: EX1000
"Soft-treat-to-target" dose titration scheme, injection s.c.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months
  • Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG less than or equal to 12 mmol/L

Exclusion Criteria:

  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Treatment with more than 1 IU/kg NPH insulin daily
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
  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: NCT00660374

Locations
Brazil
Salvador, Brazil, 40420-000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Annette Stender, M.Sc. Pharm 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: NCT00660374     History of Changes
Other Study ID Numbers: EX1000-1865
Study First Received: February 28, 2008
Last Updated: June 15, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014