A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine

NCT01704417 | Completed Phase 1

• 3 other identifiers: NN1250-39992012-000329-37U1111-1127-3402
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec (IDeg) or insulin glargine (IGlar).

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise

  From 0 to 30 minutes

Secondary Outcomes (3)

• BGmean,exe, mean blood glucose concentration during exercise

  From 0 to 30 minutes

• BGmean,30-180min,post-exe, mean blood glucose concentration

  Between 30 and 180 minutes, i.e. post-exercise

• BGminimum,30-180min,post-exe, minimum blood glucose concentration

  Between 30 and 180 minutes, i.e. post-exercise

Study Arms (2)

IDeg followed by IGlar

EXPERIMENTAL

Drug: insulin degludec; Drug: insulin glargine

IGlar followed by IDeg

EXPERIMENTAL

Drug: insulin degludec; Drug: insulin glargine

Interventions

insulin degludec DRUG

Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.

IDeg followed by IGlar; IGlar followed by IDeg

insulin glargine DRUG

Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.

IDeg followed by IGlar; IGlar followed by IDeg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-27.0 kg/m\^2 (both inclusive)
• Subjects performing regular physical cardiorespiratory activity
• Glycosylated haemoglobin (HbA1c) below or equal to 9.5 %

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 substitute products during the inpatient period
• Supine blood pressure at screening (after resting for at least 5 minutes) 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 (4)

• Heise T, Bain SC, Bracken RM, Zijlstra E, Nosek L, Stender-Petersen K, Rabol R, Rowe E, Haahr HL. Similar risk of exercise-related hypoglycaemia for insulin degludec to that for insulin glargine in patients with type 1 diabetes: a randomized cross-over trial. Diabetes Obes Metab. 2016 Feb;18(2):196-9. doi: 10.1111/dom.12588. Epub 2015 Nov 27.

  PMID: 26450456 RESULT

• McCarthy O, Pitt J, Wellman B, Eckstein ML, Moser O, Bain SC, Bracken RM. Blood Glucose Responses during Cardiopulmonary Incremental Exercise Testing in Type 1 Diabetes: A Pooled Analysis. Med Sci Sports Exerc. 2021 Jun 1;53(6):1142-1150. doi: 10.1249/MSS.0000000000002584.

  PMID: 33315813 DERIVED

• Eckstein ML, Farinha JB, McCarthy O, West DJ, Yardley JE, Bally L, Zueger T, Stettler C, Boff W, Reischak-Oliveira A, Riddell MC, Zaharieva DP, Pieber TR, Muller A, Birnbaumer P, Aziz F, Brugnara L, Haahr H, Zijlstra E, Heise T, Sourij H, Roden M, Hofmann P, Bracken RM, Pesta D, Moser O. Differences in Physiological Responses to Cardiopulmonary Exercise Testing in Adults With and Without Type 1 Diabetes: A Pooled Analysis. Diabetes Care. 2021 Jan;44(1):240-247. doi: 10.2337/dc20-1496. Epub 2020 Nov 12.

  PMID: 33184152 DERIVED

• Moser O, Eckstein ML, McCarthy O, Deere R, Bain SC, Haahr HL, Zijlstra E, Bracken RM. Poor glycaemic control is associated with reduced exercise performance and oxygen economy during cardio-pulmonary exercise testing in people with type 1 diabetes. Diabetol Metab Syndr. 2017 Nov 21;9:93. doi: 10.1186/s13098-017-0294-1. eCollection 2017.

  PMID: 29201153 DERIVED

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

DE (1)