A Trial to Investigate Post Prandial Blood Glucose Contro... | NCT02739906

Studies
A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM

NCT02739906

Sponsor

Adocia

Status

Completed

Last Update Posted

Aug 18, 2016Estimated

Enrollment

36Actual

Phase

Phase 1Phase 2

Conditions

Type 1 Diabetes Mellitus

Interventions

BioChaperone Human Insulin (HinsBet®)
Insulin Lispro (Humalog®)
Regular human insulin (Huminsulin® Normal)

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

Status Module

Record Verification Date

Aug 2016

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 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Apr 12, 2016

First Submission Date that Met QC Criteria

Apr 14, 2016

First Posted Date

Apr 15, 2016Estimated

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

Aug 17, 2016

Last Update Posted Date

Aug 18, 2016Estimated

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 is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.

Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.

Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.

The total trial duration for an individual subject will be up to 11 weeks.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
HinsBet®	Experimental	Drug: BioChaperone Human Insulin (HinsBet®)
Humalog®	Active Comparator	Drug: Insulin Lispro (Humalog®)
Huminsulin® Normal	Active Comparator	Drug: Regular human insulin (Huminsulin® Normal)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BioChaperone Human Insulin (HinsBet®)	Drug	BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake	HinsBet®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BG1h	Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal	1 hour

Secondary Outcomes

Measure	Description	Time Frame
ΔBG1h	Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal	1 hour
AUCBG,0-1h	Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subject aged 18-64 years (both inclusive).
Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
Treated with multiple daily insulin injections or CSII >= 12 months.
Current total daily insulin treatment < 1.2 (I)U/kg/day.
Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
BMI 18.5-28.0 kg/m^2 (both inclusive).
HbA1c <= 9.0 % by local laboratory analysis
Fasting C-peptide <= 0.30 nmol/L.

Exclusion Criteria:

Known or suspected hypersensitivity to IMPs or related products.
Type 2 diabetes mellitus.
Previous participation in this trial. Participation is defined as randomised.
Participation in any clinical trial within 3 months prior to this trial.
Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Profil Mainz GmbH & Co.KG		Mainz		44116	Germany
Profil GmbH

ID	Term
D003920	Diabetes Mellitus
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
D011384	Proinsulin