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

May 4, 2015 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Salvador, Brazil, 40420-000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: insulin NPH
"Soft-treat-to-target" dose titration scheme, injection s.c.
Other Names:
  • Insulatard® 100 IU/mL
Experimental: B
Drug: EX1000
"Soft-treat-to-target" dose titration scheme, injection s.c.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: For the duration of the trial
For the duration of the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: For the duration of the trial
For the duration of the trial
Fructosamine
Time Frame: For the duration of the trial
For the duration of the trial
FPG
Time Frame: For the duration of the trial
For the duration of the trial
4-point SMPG profiles
Time Frame: For the duration of the trial
For the duration of the trial
Incidence of hypoglycaemic episodes
Time Frame: For the duration of the trial
For the duration of the trial
Frequency and severity of adverse events (including injection site reactions)
Time Frame: For the duration of the trial
For the duration of the trial
Laboratory safety parameters (haematology, biochemistry and lipids)
Time Frame: For the duration of the trial
For the duration of the trial
Physical examination and vital signs
Time Frame: For the duration of the trial
For the duration of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX1000-1865

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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