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

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 0148-0000-0106 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes Mellitus, Type 2; Diabetes; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: NN1952; Drug: insulin aspart; Drug: placebo; Drug: NN1952; Drug: insulin aspart; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, 41460
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial part 1	Drug: NN1952; 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.; Drug: insulin aspart; As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.; Drug: placebo; Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.; Drug: NN1952; Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.; Drug: insulin aspart; As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.; Drug: placebo; Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
Experimental: Trial part 2	Drug: NN1952; 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.; Drug: insulin aspart; As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.; Drug: placebo; Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.; Drug: NN1952; Subjects will be randomised to receive a single dose of NN1952 with or without a meal, on two of four separate study visits. The dose will be selected based on the results of part 1.; Drug: insulin aspart; As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.; Drug: placebo; Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 7, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: NN1952-3646; U1111-1112-2892 (Other Identifier: WHO); 2009-013282-26 (EudraCT Number)