The Effect of NN1250 in Subjects With Type 2 Diabetes of... | NCT01043510

Studies
The Effect of NN1250 in Subjects With Type 2 Diabetes of Different Race and/or Ethnic Origin

NCT01043510

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jan 23, 2017Estimated

Enrollment

63Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

insulin degludec
insulin detemir

Countries

United States

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

ID	Type	Description	Link
U1111-1112-6185	Other Identifier	WHO

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

Jan 2010

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jan 5, 2010

First Submission Date that Met QC Criteria

Jan 5, 2010

First Posted Date

Jan 6, 2010Estimated

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 20, 2017

Last Update Posted Date

Jan 23, 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 the United States of America (USA). The aim of this trial is to investigate the pharmacodynamic (effect) and pharmacokinetic (exposure of drug) properties of NN1250 (insulin degludec, IDeg) in subjects with type 2 diabetes of different race and/or ethnicity.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A1, first period	Experimental	Drug: insulin degludec
A2, second period	Active Comparator	Drug: insulin detemir
B1, first period	Active Comparator	Drug: insulin detemir
B2, second period	Experimental	Drug: insulin degludec

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	0.6 U/kg body weight injected subcutaneously (under the skin), once daily for 6 days	A1, first period B2, second period

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the glucose infusion rate curve during one dosing interval at steady state		0-24 hours (derived on treatment day 6)

Secondary Outcomes

Measure	Description	Time Frame
Area under the Insulin Degludec concentration-time curve during one dosing interval at steady state		0-24 hours (derived on treatment day 6)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Either - Black or African American not of Hispanic or Latino origin or - White of Hispanic or Latino origin or - White not of Hispanic or Latino origin
Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
Treated with insulin for at least 3 months, alone or in combination with maximum 2 oral antidiabetic drugs (OADs)
Body mass index maximum 40.0 kg/m^2

Exclusion Criteria:

Use of GLP-1 receptor agonists (exenatide, liraglutide), thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to screening
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

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		Chula Vista	California	91911	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24508419	Result	Hompesch M, Morrow L, Watkins E, Roepstorff C, Thomsen HF, Haahr H. Pharmacokinetic and pharmacodynamic responses of insulin degludec in African American, white, and Hispanic/Latino patients with type 2 diabetes mellitus. Clin Ther. 2014 Apr 1;36(4):507-15. doi: 10.1016/j.clinthera.2013.12.014. Epub 2014 Feb 5.
25581159	Result

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

ID	Term
C571886	insulin degludec
D000069057	Insulin Detemir

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

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2