Back to resultsA Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NN1952
insulin aspart
placebo
NN1952
insulin aspart
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
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)
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Trial part 1
Trial part 2
Arm Description
Outcomes
Primary Outcome Measures
Number and severity of adverse events for trial part 1
Number and severity of adverse events for trial part 2
Secondary Outcome Measures
Area under the serum insulin concentration-time curve after a single dose
Area under the glucose infusion rate-time curve after a single dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01028404
Brief Title
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trial part 1
Arm Type
Experimental
Arm Title
Trial part 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NN1952
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
As an active comparator, one standard dose will be given s.c. (under the skin) at all dose levels.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will receive a single dose of placebo as a comparator to NN1952, at all dose levels.
Intervention Type
Drug
Intervention Name(s)
NN1952
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Subjects will receive a single dose of placebo as a comparator to NN1952 at one study visit.
Primary Outcome Measure Information:
Title
Number and severity of adverse events for trial part 1
Time Frame
from visit 1 to visit 3
Title
Number and severity of adverse events for trial part 2
Time Frame
from visit 1 to visit 6
Secondary Outcome Measure Information:
Title
Area under the serum insulin concentration-time curve after a single dose
Time Frame
after 12 hours
Title
Area under the glucose infusion rate-time curve after a single dose
Time Frame
after 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Two Part Trial Investigating NN1952 in Healthy Subjects and Subjects With Type 1 and Type 2 Diabetes
We'll reach out to this number within 24 hrs