A Two Part Trial Investigating NN1952 in Healthy Subjects... | NCT01028404

Studies
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

NCT01028404

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Jul 25, 2017Actual

Enrollment

84Actual

Phase

Phase 1

Conditions

Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Healthy

Interventions

NN1952
insulin aspart
placebo
NN1952
insulin aspart
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

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
U1111-1112-2892	Other Identifier	WHO
2009-013282-26	EudraCT Number

Status Module

Record Verification Date

Jul 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

Nov 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 7, 2009

First Submission Date that Met QC Criteria

Dec 7, 2009

First Posted Date

Dec 9, 2009Estimated

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

Jul 24, 2017

Last Update Posted Date

Jul 25, 2017Actual

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 investigate the safety, tolerance, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of NN1952 as tablets in healthy volunteers and subjects with type 1 and type 2 diabetes.

The trial consists of two parts. In part 1, single escalating doses of NN1952, placebo or insulin aspart will be given to healthy volunteers. In part 2, subjects with type 1 or type 2 diabetes will receive single doses of NN1952 (with/without a meal), insulin aspart and placebo.

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

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial part 1	Experimental		Drug: NN1952 Drug: insulin aspart Drug: placebo
Trial part 2	Experimental		Drug: NN1952 Drug: insulin aspart Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NN1952	Drug	Subjects will be randomised to receive a single dose of NN1952, at escalating dose levels. Progression to next dose will be based on safety evaluation.	Trial part 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number and severity of adverse events for trial part 1		from visit 1 to visit 3
Number and severity of adverse events for trial part 2		from visit 1 to visit 6

Secondary Outcomes

Measure	Description	Time Frame
Area under the serum insulin concentration-time curve after a single dose		after 12 hours
Area under the glucose infusion rate-time curve after a single dose		after 12 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

FOR TRIAL PART 1, THE FOLLOWING APPLIES:
Gender: male
Age: 18-55 years
BMI (body mass index): 18-28 kg/m2
Study participants considered to be healthy
FOR TRIAL PART 2, THE FOLLOWING APPLIES:
Gender: male or female of no childbearing potential
Age: 18-65 years
Type 1 diabetes: BMI (body mass index): 18-28 kg/m2
Type 2 diabetes: BMI (body mass index): 22-35 kg/m2
Type 1 or type 2 diabetes for at least 12 months
Type 1 diabetes: Treatment with insulin for at least 12 months
Type 2 diabetes: Treatment with insulin for at least 3 months

Exclusion Criteria:

Known or suspected allergy to the trial product or related products
Presence of illness or infection that may confound the results of the study or pose a risk to the study participant by dosing NN1952, as judged by the Investigator
Presence of acute gastrointestinal symptoms (for example nausea, vomiting, heartburn or diarrhoea)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

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		Neuss		41460	Germany

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061267	Insulin Aspart

Ancestor Terms

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided