Detemir Energy Expenditure Study | NCT00788840

Studies
Detemir Energy Expenditure Study

NCT00788840

Sponsor

University of Surrey

Status

Completed

Last Update Posted

May 31, 2023Actual

Enrollment

30Actual

Phase

Phase 4

Conditions

Type 2 Diabetes Mellitus
Obesity

Interventions

Insulatard
Detemir

Countries

United Kingdom

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

May 2023

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

Jan 2008Actual

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Nov 10, 2008

First Submission Date that Met QC Criteria

Nov 10, 2008

First Posted Date

Nov 11, 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

May 26, 2023

Last Update Posted Date

May 31, 2023Actual

Name	Class
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1. Insulatard	Active Comparator		Drug: Insulatard
2. Detemir	Active Comparator		Drug: Detemir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulatard	Drug	Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.	1. Insulatard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight change		6 months

Secondary Outcomes

Measure	Description	Time Frame
Energy Expenditure		6 months
Fat composition		6 months
Fat & muscle gene expression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes
Treated with metformin
Already on treatment with a long-acting or intermediate insulin.
Over 18 years of age,
HbA1c > 7.0%
BMI 27-40
Able and willing to perform self-blood glucose monitoring.
Able and willing to maintain consistent eating habits throughout the entire trial period.
Able and willing to maintain consistent physical activity level during the entire trial period

Exclusion Criteria:

Patients on sulphonylureas or thiazolidinediones
Proliferative retinopathy that has required acute treatment within the last six months.
Impaired hepatic or renal functions.
Cardiac problems.
Uncontrolled hypertension (treated or untreated).
Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.

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
David Russell-Jones, MB BS	University of Surrey	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedar Centre, Royal Surrey County Hospital		Guildford	Surrey	GU2 7XX	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33166419	Derived	Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000068880	Isophane Insulin, Human
D000069057	Insulin Detemir

ID	Term
D007336	Insulin, Isophane
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones