Comparing Long-acting Insulins During Exercise in Type 1 Diabetes

NCT01440439 | Unknown Phase 4

• 3 other identifiers: RXQ4252011-001209-28U1111-1119-8890
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes like to take part in regular sport and exercise. The majority of people with Type 1 Diabetes are treated with a "basal bolus" insulin regimen, with background insulin provided by long-acting "basal" insulin doses, and "bolus" doses of short-acting insulin used to accompany food intake. Evidence shows that the main factor preventing people with diabetes from pursuing a more active lifestyle is fear of low blood glucose (hypoglycaemia). A previous study has shown that the type of background insulin affects the likelihood of an individual suffering hypoglycaemia during exercise and for 2 and a half hours afterwards. The aim of this study is to examine this further. The two most commonly used long-acting insulins, insulin glargine and insulin detemir, will be compared. Previous data suggests that there is a greater likelihood of hypoglycaemia with insulin glargine than insulin detemir. Exercise intensity can have an influence on the likelihood of hypoglycaemia, and in this previous study exercise intensity was measured using heart rate. This study will use a more formal definition of exercise intensity. The investigators will study blood glucose during exercise, but also metabolism as measured by hormones affecting blood glucose levels as well as markers of fat metabolism. The investigators will also use a continuous glucose monitoring system (CGMS) to consider hypoglycaemia on thei night following exercise as this is a recognised consequence of exercise in type 1 diabetes. The null hypothesis to be tested in this study is that there is no difference between the two insulins in their effect on blood glucose levels and metabolism during exercise and rates of nocturnal hypoglycaemia after exercise.

Conditions

Diabetes Mellitus, Type 1

Keywords

insulin glargine; insulin detemir; hypoglycaemia; metabolism; Exercise

Outcome Measures

Primary Outcomes (1)

• Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise)

  The measure will be a comparison between the two conditions (treatment with insulin detemir or treatment with insulin glargine) of the change in blood glucose levels during one hour of sub-maximal exercise at 50% VO2 MAX

  Between baseline and 1 hour

Secondary Outcomes (13)

• Lactate

  0, 60 and 90 minutes

• NEFA (Non-esterified fatty acids)

  0, 60 and 90 minutes

• B-OHB (beta-hydroxybutyrate)

  0, 60 and 90 minutes

• Catecholamines

  0, 60 and 90 minutes

• Glucagon

  0, 60 and 90 minutes

Study Arms (2)

Insulin detemir

ACTIVE COMPARATOR

Metabolism during and after submaximal exercise during treatment with insulin detemir

Drug: Insulin detemir

Insulin glargine

ACTIVE COMPARATOR

Metabolism during and after submaximal exercise during treatment with insulin glargine

Drug: Insulin glargine

Interventions

Insulin glargine DRUG

Use of insulin glargine as basal insulin for treatment of Type 1 Diabetes Mellitus

Also known as: Lantus

Insulin glargine

Insulin detemir DRUG

Use of insulin detemir as basal insulin for treatment of Type 1 Diabetes Mellitus

Also known as: Levemir

Insulin detemir

Eligibility Criteria

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

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged between 18 and 65 years
• Diagnosed with Type 1 Diabetes Mellitus (T1DM)
• HbA1c \< 10% or 86 mmol/mol
• Treated with a basal bolus regimen using either insulin glargine or insulin detemir as the basal insulin
• Exercising regularly for at least 1 hour per week on average

You may not qualify if:

• People with any one of the following complications of diabetes:
• stage 2+ diabetic retinopathy
• renal impairment (with creatinine \>150micromol/l)
• known history or symptoms of cardiovascular disease
• foot ulceration
• peripheral vascular disease
• Pregnancy or breastfeeding
• Untreated or unstable respiratory disease
• Known hypoglycaemia unawareness
• Treatment with drugs known to interfere with glucose metabolism
• Known or suspected allergy to or intolerance of any of the trial drugs or related products
• Receipt of any investigational drug within four months prior to Visit 0
• Known or suspected abuse of alcohol, narcotics or illicit drugs
• Any clinically significant disease or disorder which in the investigator's opinion could interfere with the results of the trial

Sponsors & Collaborators

• Buckinghamshire Healthcare NHS Trust: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Wycombe Hospital

High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Interventions

Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

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

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

• Ian W Gallen, MD FRCP

  Bcukinghamshire Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alistair N Lumb, MBBS MRCP

CONTACT

+441494425349/+44757007703; sportsdiabetes@hotmail.co.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 26, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

GB (1)