Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes
1 other identifier
interventional
397
3 countries
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 diabetes
Started Jun 2008
Shorter than P25 for phase_2 diabetes
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedApril 14, 2015
April 1, 2015
9 months
June 16, 2008
April 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
after 8 weeks of treatment
Secondary Outcomes (9)
HbA1c
For the duration of the trial
Fructosamine
For the duration of the trial
FPG
For the duration of the trial
4-point SMPG profiles
For the duration of the trial
Incidence of hypoglycaemic episodes
For the duration of the trial
- +4 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (3)
Unknown Facility
Vijayawada, 520002, India
Unknown Facility
Johannesburg, Gauteng, 2193, South Africa
Unknown Facility
Abu Dhabi, 51900, United Arab Emirates
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2008
First Posted
June 17, 2008
Study Start
June 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
April 14, 2015
Record last verified: 2015-04