- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00698802
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
April 13, 2015 updated by: Novo Nordisk A/S
Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
This trial is conducted in Asia and Africa.
This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
397
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
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Vijayawada, India, 520002
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Gauteng
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Johannesburg, Gauteng, South Africa, 2193
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Abu Dhabi, United Arab Emirates, 51900
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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 biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 9.5%
- FPG (SMPG) less than or equal to 12 mmol/L
Exclusion Criteria:
- Treatment with more than 1IU/kg insulin daily
- Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- 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: B
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Treat-to-target titration scheme, s.c.
injection
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Experimental: A
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Treat-to-target titration scheme, s.c.
injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: after 8 weeks of treatment
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after 8 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: For the duration of the trial
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For the duration of the trial
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Fructosamine
Time Frame: For the duration of the trial
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For the duration of the trial
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FPG
Time Frame: For the duration of the trial
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For the duration of the trial
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4-point SMPG profiles
Time Frame: For the duration of the trial
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For the duration of the trial
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Incidence of hypoglycaemic episodes
Time Frame: For the duration of the trial
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For the duration of the trial
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Frequency and severity of adverse events (including injection site reactions)
Time Frame: For the duration of the trial
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For the duration of the trial
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Laboratory safety parameters (haematology, biochemistry and lipids)
Time Frame: For the duration of the trial
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For the duration of the trial
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Physical examination and vital signs
Time Frame: For the duration of the trial
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For the duration of the trial
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Total daily insulin dosages
Time Frame: For the duration of the trial
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For the duration of the trial
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
June 16, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Estimate)
April 14, 2015
Last Update Submitted That Met QC Criteria
April 13, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EX1000-1919
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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