A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

NCT01114542 | Completed Phase 1

• 3 other identifiers: NN1250-19932009-015897-36U1111-1113-6772
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state

  0-24 hours after dosing on day 8

Secondary Outcomes (3)

• Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state

  0-24 hours after dosing on day 8

• Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec

  0-24 hours after dosing on day 8

• Area under the concentration-time curve during one dosing interval at steady state for insulin glargine

  0-24 hours after dosing on day 8

Study Arms (6)

IDeg 0.4 U/kg

EXPERIMENTAL

Drug: insulin degludec

IDeg 0.6 U/kg

EXPERIMENTAL

Drug: insulin degludec

IDeg 0.8 U/kg

EXPERIMENTAL

Drug: insulin degludec

IGlar 0.4 U/kg

ACTIVE COMPARATOR

Drug: insulin glargine

IGlar 0.6 U/kg

ACTIVE COMPARATOR

Drug: insulin glargine

IGlar 0.8 U/kg

ACTIVE COMPARATOR

Drug: insulin glargine

Interventions

insulin degludec DRUG

Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

IDeg 0.4 U/kg; IDeg 0.6 U/kg; IDeg 0.8 U/kg

insulin glargine DRUG

Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)

IGlar 0.4 U/kg; IGlar 0.6 U/kg; IGlar 0.8 U/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Current total daily insulin treatment lower than 1.2 (I)U/kg/day
• Body mass index 18.0-28.0 kg/m\^2

You may not qualify if:

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
• Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (3)

• Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.

  PMID: 25581159 RESULT

• Heise T, Hovelmann U, Nosek L, Hermanski L, Bottcher SG, Haahr H. Comparison of the pharmacokinetic and pharmacodynamic profiles of insulin degludec and insulin glargine. Expert Opin Drug Metab Toxicol. 2015;11(8):1193-201. doi: 10.1517/17425255.2015.1058779. Epub 2015 Jun 18.

  PMID: 26086190 RESULT

• Heise T, Kaplan K, Haahr HL. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. J Diabetes Sci Technol. 2018 Mar;12(2):356-363. doi: 10.1177/1932296817731422. Epub 2017 Sep 26.

  PMID: 28946756 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: May 3, 2010
• Primary Completion: August 10, 2010
• Study Completion: August 10, 2010
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

DE (1)