Type 1 Diabetes Clinical Trial
— DAWNOfficial title:
Comparison of Lantus and NPH Insulin in the Dawn Phenomenon
Verified date | October 2014 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 (Acromegaly, Cushing's, Hypothyroidism etc.) or tumor. - Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Massachusettes General Hospital/ Diabetes Research Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Glucose Area Under the Curve (AUC) | Cumulative sum of repeatedly measured blood glucose values (mg/dl) beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on neutral protamine Hagedorn (NPH) insulin as the long acting insulin; the other overnight was glargine (Lantus) insulin as the the long acting insulin. | Overnight | No |
Primary | Blood Glucose | Average value of repeatedly measured absolute values beginning at 22:00, then hourly till 08:00. Participants were monitored during two overnight sampling periods. One overnight was while the participant was on NPH insulin as the long acting insulin; the other overnight was glargine(Lantus) insulin as the the long acting insulin. | Overnight | No |
Secondary | Insulin Dose | NPH or glargine (Lantus) was given at 22:00 to provide blood glucose coverage during the overnight hours. | Overnight | No |
Secondary | Cortisol | Mean cortisol nmol/l during NPH or glargine (Lantus) overnight visit. Hourly cortisol was determined from 22:00 to 8:00. | Overnight | No |
Secondary | Glucagon | Mean glucagon mcg/l during NPH or glargine (Lantus) overnight visit. Hourly glucagon was determined from 22:00 to 8:00. | Overnight | No |
Secondary | Growth Hormone | Mean growth hormone ug/l during NPH or glargine (Lantus) overnight visit. Hourly growth hormone was determined from 22:00 to 8:00. | Overnight | No |
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