CompletedPhase 3

Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon

United States27 participantsStarted 2005-06

Plain-language summary

1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding glycemic control during the early AM (dawn phenomenon) in individuals with type 1 diabetes. 2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals with type 1 diabetes.

Who can participate

Age range

18 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: * Written informed consent obtained prior to performing screening evaluations. * Male or female, 18 yrs or older. * Diagnosis of type 1 diabetes made 5 years prior to screening visit. * A1C \> 6.0% and 9.0% at screening visit. * Body Mass Index (BMI) 35 kg/m2 at screening visit. * Documented undetectable C-Peptide * Ability to follow instructions for Continuous Glucose Monitoring System (CGMS). * Multiple daily injection participants on at least 3 injections per day. May be treated with NPH or glargine. Exclusion Criteria: * Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception. Females of childbearing potential must have a negative pregnancy test at Visit 3 and Visit 5. Females who become pregnant during the study will be discontinued. * Type 2 diabetes. * Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening. * Drugs known to affect glycemia (eg. steroids, beta blockers) or conditions that are likely to require steroid therapy or cause metabolic instability in the next 6 months. * History of allergy or intolerance to NPH or glargine. * History of hypoglycemia unawareness i.e. no warning symptoms accompanying low (\<50 mg/dl) blood glucose levels. * Unable and/or unlikely to comprehend and/or follow the study protocol (including self blood glucose monitoring, CGMS). * Currently using an insulin pump. * Pituitary disorder (Acromeg…

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

Blood Glucose Area Under the Curve (AUC)

Timeframe: Overnight

Blood Glucose

Timeframe: Overnight

Trial details

NCT IDNCT00694122

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

Results submitted2013-11-04

View on ClinicalTrials.gov More Type 1 Diabetes trials

Who can participate

Age range

18 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.