Phase 3
Completed N=27
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
Type 1 Diabetes · Dawn Phenomenon
Source: ClinicalTrials.gov NCT00694122 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Blood Glucose Area Under the Curve (AUC) — 1673.33; 1395 mg*10hr/dL — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Glucose Area Under the Curve (AUC) |
1673.33; 1395 | <0.05 sig |
| PRIMARY Blood Glucose |
9.6; 7.9 | <0.05 sig |
| SECONDARY Insulin Dose |
20.2; 20.7 | <0.05 sig |
| SECONDARY Cortisol |
380.45; 388.61 | — |
| SECONDARY Glucagon |
58.8; 54.3 | — |
| SECONDARY Growth Hormone |
1.09; 1.27 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00694122). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.