Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | April 30, 2007 | ||||
Last Updated Date | August 29, 2007 | ||||
Start Date † | July 2003 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00468364 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes | ||||
Official Title † | Comparison of Carbohydrate Metabolism During the Night and at Hypoglycemia in Type-2 Diabetic Patients Either on Glargine or NPH Insulin | ||||
Brief Summary | Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night in patients with diabetes. The aims of the study are 1) to compare the dynamic characteristics of long-acting insulin analog glargine with those of NPH insulin and placebo during the night and the early morning hours, 2) investigate differences on glucose metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia. |
||||
Detailed Description | Patients with advanced type 2 diabetes like those with type 1 diabetes are at risk for defective glucose counterregulation and hypoglycemia unawareness, the components of hypoglycemia-associated autonomic failure and the resultant vicious cycle of recurrent iatrogenic hypoglycemia. This may explain why iatrogenic hypoglycemia becomes limiting to glycemic control as patients approach the insulin-deficient end of the spectrum of type 2 diabetes. Compared to Neutral Protamin Hagedorn (NPH) insulin glargine is a new long-acting peakless analogue with lower incidence of nocturnal hypoglycemia having the potential to decrease the frequency of hypoglycemia of insulin therapy. Modern type 2 diabetes therapy guidelines recommend insulin for an increasing population of patients. There is no doubt that type 2 diabetic patients suffer from hypoglycemia under insulin therapy, however it is not clear whether the extensive studies on hypoglycemia in type 1 patients apply also for type 2 diabetes. Recent reports indicate that type 2 diabetic patients of long duration react similarly to a hypoglycemic clamp as type 1 diabetic patients while well controlled type 2 diabetics had even more favorable thresholds for counter-regulatory hormone secretion. On the basis of these considerations the aims of this study are to 1) more precisely define the mechanisms of hypoglycemia in type 2 diabetes, 2) to investigate differences on glucose and lactate metabolism of bedtime NPH insulin versus glargine. To address these objectives we will use the hypoglycemic clamping technique combined with infusion of stable isotopes of glucose and lactate and non-invasive measurement of muscle flow characteristics at hypoglycemia. |
||||
Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Natural History, Cross-Sectional, Defined Population, Prospective Study | ||||
Condition † | Diabetes | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups | |||||
Publications * | Yki-Jarvinen H, Kauppinen-Makelin R, Tiikkainen M, Vahatalo M, Virtamo H, Nikkila K, Tulokas T, Hulme S, Hardy K, McNulty S, Hanninen J, Levanen H, Lahdenpera S, Lehtonen R, Ryysy L. Insulin glargine or NPH combined with metformin in type 2 diabetes: the LANMET study. Diabetologia. 2006 Mar;49(3):442-51. Epub 2006 Feb 3. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 12 | ||||
Completion Date | March 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Germany | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00468364 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | University of Giessen | ||||
Collaborators †† | Sanofi-Aventis | ||||
Investigators † |
|
||||
Information Provided By | University of Giessen | ||||
Verification Date | August 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |