Safety and Efficacy of Biphasic Human Insulin Compared to... | NCT00698802

Studies
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

NCT00698802

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Apr 14, 2015Estimated

Enrollment

397Actual

Phase

Phase 2

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

EX1000
biphasic human insulin

Countries

India
South Africa
United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jun 16, 2008

First Submission Date that Met QC Criteria

Jun 16, 2008

First Posted Date

Jun 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

397Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: EX1000
B	Active Comparator		Drug: biphasic human insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EX1000	Drug	Treat-to-target titration scheme, s.c. injection	A
biphasic human insulin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		after 8 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
HbA1c		For the duration of the trial
Fructosamine		For the duration of the trial
FPG

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Vijayawada		520002	India

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C575870	biphasic human insulin 30

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided