Comparison of IDegAsp (Inclusive Three Explorative Formul... | NCT01868568

Studies
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes

NCT01868568

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 22, 2015Estimated

Enrollment

55Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 1

Interventions

insulin degludec
insulin degludec/insulin aspart 30
insulin degludec/insulin aspart 40
insulin degludec/insulin aspart 45
insulin degludec/insulin aspart 55
insulin aspart
biphasic insulin aspart 30
placebo

Countries

Germany

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

ID	Type	Description	Link
2007-006110-42	EudraCT Number

Official Title

A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes

Status Module

Record Verification Date

Oct 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

Apr 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

May 30, 2013

First Submission Date that Met QC Criteria

May 30, 2013

First Posted Date

Jun 4, 2013Estimated

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

Oct 21, 2015

Last Update Posted Date

Oct 22, 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 Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.

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

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
IDegAsp 30 + placebo	Experimental	Drug: insulin degludec/insulin aspart 30 Drug: placebo
Insulin aspart + insulin degludec - low concentration 1	Experimental	Drug: insulin degludec Drug: insulin aspart
IDegAsp 40 + placebo	Experimental	Drug: insulin degludec/insulin aspart 40 Drug: placebo
Insulin aspart + insulin degludec - high concentration 1	Experimental	Drug: insulin degludec Drug: insulin aspart
IDegAsp 45 + placebo	Experimental	Drug: insulin degludec/insulin aspart 45 Drug: placebo
Insulin aspart + insulin degludec	Experimental	Drug: insulin degludec Drug: insulin aspart
IDegAsp 55 + placebo	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Administered subcutaneously (s.c., under the skin).	Insulin aspart + insulin degludec Insulin aspart + insulin degludec - high concentration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the insulin aspart concentration curve		0-2 hours after dosing

Secondary Outcomes

Measure	Description	Time Frame
Area under the glucose infusion rate curve		0-26 hours after dosing
Area under the serum insulin 454 concentration curve		0-120 hours after dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months
Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the Investigator
A subject who is known to have hepatitis or who is carrier of the Hepatitis B surface antibodies, or has a positive result to the test for HIV antigen (HBsAg) or Hepatitis C antibodies
A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
		Neuss		41460	Germany

Label	URL
Clinical Trials at Novo Nordisk	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Term
C571886	insulin degludec
D061267	Insulin Aspart
C557564	insulin aspart, insulin aspart protamine drug combination 30:70

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1