Comparison of Explorative Formulation of Insulin Degludec... | NCT01865305

Studies
Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With Diabetes

NCT01865305

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Oct 23, 2015Estimated

Enrollment

59Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Interventions

insulin degludec/insulin aspart 30
insulin degludec/insulin aspart 40
insulin degludec/insulin aspart 50
insulin degludec
insulin aspart
biphasic insulin aspart 30
insulin degludec/insulin aspart 40
insulin degludec/insulin aspart 50
biphasic insulin aspart 30

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
2006-002430-37	EudraCT Number

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

Sep 2006

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

May 27, 2013

First Submission Date that Met QC Criteria

May 27, 2013

First Posted Date

May 30, 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 22, 2015

Last Update Posted Date

Oct 23, 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 different ratios of explorative formulations, not similar to the proposed commercial formulation, of IDegAsp (co-formulation of insulin degludec/insulin aspart and insulin aspart) with separately injected, simultaneous doses of insulin degludec (insulin 454), and insulin aspart, compared with biphasic insulin aspart 30 in male subjects with type 1 and type 2 diabetes mellitus.

Trial part 1 is a five-period cross-over trial with incomplete block-design in subjects with type 1 diabetes where each subject will be randomised to five out of the ten possible treatments. Each treatment consists of an injection of the insulin product followed by a euglycemic clamp with a washout period of 7-15 days between treatments.

Trial part 2 is a three-period cross-over trial with complete blockdesign in subjects with type 2 diabetes. Each treatment consists of an injection of the insulin product followed by a euglycaemic clamp with a washout period of 7-15 days between treatments.

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

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial part 1	Experimental		Drug: insulin degludec/insulin aspart 30 Drug: insulin degludec/insulin aspart 40 Drug: insulin degludec/insulin aspart 50 Drug: insulin degludec Drug: insulin aspart Drug: biphasic insulin aspart 30
Trial part 2	Experimental		Drug: insulin degludec/insulin aspart 40 Drug: insulin degludec/insulin aspart 50 Drug: biphasic insulin aspart 30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec/insulin aspart 30	Drug	Single dose administrated subcutaneously (s.c., under the skin).	Trial part 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)		0-2 hours after dosing
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)		0-24 hours after dosing

Secondary Outcomes

Measure	Description	Time Frame
Area under the glucose infusion rate curve		0-24 hours after dosing
Area under the serum insulin degludec concentration curve		0-96 hours after dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)
ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
Diagnosed with type 2 diabetes mellitus for at least 12 months
Treated with insulin for the last 3 months prior to screening.
Body Mass Index (BMI) between 22.0 and 35.0 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 trial product, as judged by the Investigator
A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

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
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1
D003924	Diabetes Mellitus, Type 2