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

Phase 1

Completed

• Conditions: Healthy; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: NN1952; Drug: insulin aspart; Drug: placebo

• Registration Number: NCT01028404
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial part 1	NN1952	-
Trial part 1	insulin aspart	-
Trial part 1	placebo	-
Trial part 2	NN1952	-
Trial part 2	insulin aspart	-
Trial part 2	placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany