Comparison of Lantus and NPH Insulin in the Dawn Phenomenon
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Type 1 Diabetes Dawn Phenomenon |
Intervention | Drug: alternate long acting insulin, either NPH or Lantus |
Phase | Phase 3 |
Sponsor | Massachusetts General Hospital |
Responsible Party | Massachusetts General Hospital |
ClinicalTrials.gov Identifier | NCT00694122 |
First Received | June 6, 2008 |
Last Updated | July 28, 2010 |
Last verified | July 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | June 6, 2008 |
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Last Updated Date | July 28, 2010 |
Start Date | June 2005 |
Estimated Primary Completion Date | November 2010 |
Current Primary Outcome Measures | Hourly blood glucose, cortisol, growth hormone, glucagon, and insulin levels [Time Frame: Overnight testing from 20:00 to 08:00] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | Subject preference to insulin type [Time Frame: During each intervention period (3-4 weeks)] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of Lantus and NPH Insulin in the Dawn Phenomenon |
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Official Title | Comparison of Lantus and NPH Insulin in the Dawn Phenomenon |
Brief 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. |
Detailed Description | Title: COMPARISON of LANTUS and NPH INSULIN IN THE DAWN PHENOMENON I. Background and Significance Diabetes mellitus affects greater than 6% of the population, with type 2 more prevalent than type 1. For individuals with type 1 diabetes, the challenge has been to replicate insulin secretion of the healthy pancreas to maintain blood glucose as close to the non-diabetic range as possible. Insulin regimes using insulins with varied activity profiles (multiple daily injections or MDI) and continuous subcutaneous insulin infusion (CSII) have been somewhat successful in "mimicking" normal pancreatic function (1, 2). For individuals with type 1 diabetes, the benefits of near-normal, long-term glycemic control in delaying the development and slowing the progression of long-term complications was demonstrated in the Diabetes Control and Complications Trial (3). Intensive insulin therapy to achieve near-normal glycemic control has been limited by a three-fold increase in episodes of hypoglycemia (3, 4). Insulin analogs that provide more stable physiologic insulin levels have led to the development of newer MDI regimes (5). Glargine (Lantus) is a long-acting recombinant human insulin analog demonstrated to provide a continuous, smooth supply of insulin with no pronounced peak over a 24-hour period (6). An increase in blood glucose in type 1 and type 2 diabetics, and an increase in insulin secretion to maintain normoglycemia in non-diabetics, was documented in several studies in the 1980s (15-17). This physiological requirement for more insulin delivery (or secretion) in the early (4:00-6:00 AM) hours was termed the "dawn phenomenon". The mechanism for the dawn phenomenon was thought to be the overnight increase in growth hormone section, rather than diurnal glucocorticoids (16, 18, 19). Most intensive treatment regimens of the 1980-90's, with MDI or CSII, were designed to provide more insulin in the 4:00-7:00 AM period to cope with the dawn phenomenon which cannot be be achieved with glargine (20-21). Continuous monitoring of blood glucose has revealed that individuals treated with CSII had significantly better glycemic control than glargine treated individuals (22). Whether the dawn phenomenon, with increased area under the curve blood glucose levels during the dawn period is limiting the effectiveness of regimens with glargine is of crucial importance. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: alternate long acting insulin, either NPH or Lantus NPH or Lantus, dose individualized for subject |
Study Arm (s) | Experimental: v3 Long acting insulin that subject currently uses |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 18 |
Estimated Completion Date | November 2010 |
Estimated Primary Completion Date | November 2010 |
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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: CHRISTINE STEVENS, RN 617-643-0915 CSTEVENS@PARTNERS.ORG |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00694122 |
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Other Study ID Numbers | 2005-P-002515/24 |
Has Data Monitoring Committee | Yes |
Information Provided By | Massachusetts General Hospital |
Study Sponsor | Massachusetts General Hospital |
Collaborators | Sanofi |
Investigators | Principal Investigator: David M Nathan, MD Massachusetts General Hospital |
Verification Date | July 2010 |
Locations[ + expand ][ + ]
Massachusettes General Hospital/ Diabetes Research Center | Boston, Massachusetts, United States, 02114 Contact: CHRISTINE R STEVENS, RN | 617-643-0915Principal Investigator: DAVID M NATHAN, MD Recruiting |
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