CompletedPhase 3

Frequency of Hypoglycaemic Episodes During Treatment With Insulin Detemir in Well Controlled Subjects With Type 1 Diabetes

Australia, Croatia, Denmark131 participantsStarted 2001-09

Plain-language summary

This trial is conducted in Africa, Europe and Oceania. The aim of this trial is to investigate whether insulin detemir combined with insulin aspart compared to NPH insulin combined with insulin aspart could reduce the frequency of hypoglycaemic episodes whilst maintaining the same degree of glycaemic control subjects with type 1 diabetes.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Type 1 diabetes * Fasting c-peptide below lower limit of normal fasting range * Duration of type 1 diabetes for at least 12 months * Current treatment: Basal - bolus regimen for at least 4 months with intermediate or long-acting insulin once, twice or three times daily as basal insulin and 3-4 premeal insulin aspart or lispro injections * HbA1c maximum 9.0% (using Biorad Variant method) * Able and willing to perform self-monitoring of blood glucose * Basal insulin requirement at least 30% of the total daily insulin dose * BMI (body Mass Index) maximum 35 kg/m\^2 Exclusion Criteria: * Proliferative retinopathy or maculopathy requiring acute treatment * Total daily insulin dose above 1.4 IU/kg/day * Known unawareness of hypoglycaemia * Impaired hepatic function * Impaired renal function * Cardiac problems * Uncontrolled, treated/untreated hypertension * Known or suspected allergy to trial product or related products

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of total self-recorded hypoglycaemic episodes

Trial details

NCT IDNCT01697657

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2002-11

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