Safety and Efficacy of Insulin Detemir in Combination Wit... | NCT00592527

Studies
Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes

NCT00592527

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 27, 2017Estimated

Enrollment

132Actual

Phase

Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin detemir

Countries

India

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

Jan 2017

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

Apr 2004

Primary Completion Date

Dec 2004Actual

Completion Date

Dec 2004Actual

First Submitted Date

Jan 2, 2008

First Submission Date that Met QC Criteria

Jan 2, 2008

First Posted Date

Jan 14, 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

Jan 26, 2017

Last Update Posted Date

Jan 27, 2017Estimated

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.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1c		after 20 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Fasting plasma glucose (FPG)
Within-subject variation
Change in body weight

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes for at least 12 months since diagnosis
Insulin naive subjects
OAD treatment for at least 4 months with max. two OAD treatments
Body mass index below 30.0 kg/m2
HbA1c between 7.0-11.0%

Exclusion Criteria:

OAD treatment with three or more OADs
Secondary diabetes
Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
Uncontrolled hypertension
Known or suspected allergy to trial product or related products

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
Novo Nordisk Investigational Site		Kochi	Kerala	682041	India
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Ramachandran A, Harish K, Sundaram A, Mayur P, Sunil GS, Srishyla MV. Improved Efficacy when Insulin Detemir is added to OADs in Indian Subjects with Type 2 Diabetes. Diabetes 2006; 55 (Suppl. 1): A469 (2028-PO)

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

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2