Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440284
Status:
UNKNOWN
Last Update Posted:
2007-02-27
First Post:
2007-02-21
Brief Title:
Flexible Intensive vs Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes
Sponsor:
University of Jena
Organization:
University of Jena
Study Overview
Official Title:
Flexible Intensive vs Conventional Insulin Therapy in Insulin-Naive Adults With Type 2 Diabetes - a Non-Blinded Randomized Controlled Cross-Over Clinical Trial of Metabolic Control and Patient Preference
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective Flexible intensive insulin therapy FIT with pre-prandial regular insulin and conventional insulin therapy CIT with twice daily premixed insulin are treatment options in patients with type 2 diabetes who become insulin dependent While intensive insulin therapy can increase meal and life style flexibility conventional therapy is easier to perform The aim of the study was to compare metabolic outcomes and patient preferences of both treatment regimens
Research Design and Methods Non-blinded randomized controlled cross-over clinical pilot trial Insulin naive participants who failed therapeutic goals under oral antidiabetic therapy underwent FIT and CIT for two months Patients completed standard Diabetes Treatment and Teaching Programs DTTP and trained FIT and CIT Main outcome measures were glycosylated hemoglobin GHb mild and severe hypoglycemia insulin dosage blood pressure and body-mass-index BMI Beforeafter and inter-group analyses were performed Finally therapy preference was analyzed
Research Design and Methods Non-blinded randomized controlled cross-over clinical pilot trial Insulin naive participants who failed therapeutic goals under oral antidiabetic therapy underwent FIT and CIT for two months Patients completed standard Diabetes Treatment and Teaching Programs DTTP and trained FIT and CIT Main outcome measures were glycosylated hemoglobin GHb mild and severe hypoglycemia insulin dosage blood pressure and body-mass-index BMI Beforeafter and inter-group analyses were performed Finally therapy preference was analyzed
Detailed Description:
Hypothesis In the undertaken study we tested the hypothesis that flexible intensive and conventional insulin therapy in insulin-naive adults with type 2 diabetes are equally effective in regards to metabolic outcomes We hypothesized that younger participants in employment would prefer flexible intensive insulin therapy
Flexible intensive and conventional insulin therapy CIT consisted of twice daily injections of premixed insulin 30 regular insulin 70 NPH-insulin before breakfast and dinner Participants followed individually adjusted diet plans with fixed amounts of carbohydrates Daily blood-glucose self-control was performed before insulin injections Participants documented blood glucose readings and insulin dosage Limited self-adjustment of insulin dosage was taught and encouraged in the DTTP ie variance of up to 4 IU insulin per injection
In FIT participants measured blood glucose before main meals and at bedtime and adjusted regular insulin dosages to actual blood glucose levels and their desired carbohydrate intake on a meal by meal basis When necessary NPH insulin was added at bedtime Additional administration of oral antidiabetic drugs was not permitted
Study design randomization and intervention The trial was designed as a clinical prospective randomized non-blinded single center cross-over pilot study
After randomization participants started insulin therapy either with FIT or CIT and completed a Diabetes Treatment and Teaching Program on an out-patient basis In this four week run-in period with weekly visits individual insulin dosage and carbohydrate intake was determined figure 1 The run-in was followed by an 8 week study sequence until cross-over At cross-over participants were given one structured teaching session for refreshing and switched from CIT to FIT Group A or FIT to CIT Group B respectively After a one week run-in period for insulin dose-adjustment participants completed the second 8 week study sequence Regular visits were held at the beginning and at the end of both study sequences Additional visits were held after 2 weeks to adjust therapy if necessary During visits a study team consisting of a diabetologist and a specially trained nurse educator analyzed personal diabetes records and gave advice regarding insulin dose adjustment and other problems related to current diabetes therapy At the end of the trial participants decided which therapy to continue
Setting eligibility criteria and outcome measures Participants were recruited in the outpatient clinic of the Unit of Endocrinology and Metabolic Diseases of the Department of Internal Medicine of the Friedrich-Schiller-University Jena
All patients with type 2 diabetes who failed to achieve their therapeutic goals under oral antidiabetic therapy and who were referred by local General Practitioners to the outpatient clinic for initiation of insulin therapy were candidates for inclusion in the study Participants who agreed to participate in the study were recruited in consecutive order as they were referred to the out-patient clinic They were not admitted to the study if any of the following criteria were present 1 not type 2 diabetes 2 diabetes duration 2 years 3 not insulin naive 4 ineffective oral antidiabetic therapy 3 months 5 GHb below 7 or above 11 6 age below 40 or above 65 years 7 co-medication with corticosteroids 8 pregnancy severe mental or somatic diseases or 9 unwillingness to return for follow-up
The primary end-point with respect to the effectiveness of FIT and CIT was glycosylated GHb Secondary end-points were mild and severe symptoms of hypoglycemia insulin dosage blood pressure BMI and individual therapy preference
Sample size To have a 90 chance of detecting as significant at the two sided 5 level a 05 difference between the two groups in GHb with an assumed standard deviation of 08 38 participants were required
Flexible intensive and conventional insulin therapy CIT consisted of twice daily injections of premixed insulin 30 regular insulin 70 NPH-insulin before breakfast and dinner Participants followed individually adjusted diet plans with fixed amounts of carbohydrates Daily blood-glucose self-control was performed before insulin injections Participants documented blood glucose readings and insulin dosage Limited self-adjustment of insulin dosage was taught and encouraged in the DTTP ie variance of up to 4 IU insulin per injection
In FIT participants measured blood glucose before main meals and at bedtime and adjusted regular insulin dosages to actual blood glucose levels and their desired carbohydrate intake on a meal by meal basis When necessary NPH insulin was added at bedtime Additional administration of oral antidiabetic drugs was not permitted
Study design randomization and intervention The trial was designed as a clinical prospective randomized non-blinded single center cross-over pilot study
After randomization participants started insulin therapy either with FIT or CIT and completed a Diabetes Treatment and Teaching Program on an out-patient basis In this four week run-in period with weekly visits individual insulin dosage and carbohydrate intake was determined figure 1 The run-in was followed by an 8 week study sequence until cross-over At cross-over participants were given one structured teaching session for refreshing and switched from CIT to FIT Group A or FIT to CIT Group B respectively After a one week run-in period for insulin dose-adjustment participants completed the second 8 week study sequence Regular visits were held at the beginning and at the end of both study sequences Additional visits were held after 2 weeks to adjust therapy if necessary During visits a study team consisting of a diabetologist and a specially trained nurse educator analyzed personal diabetes records and gave advice regarding insulin dose adjustment and other problems related to current diabetes therapy At the end of the trial participants decided which therapy to continue
Setting eligibility criteria and outcome measures Participants were recruited in the outpatient clinic of the Unit of Endocrinology and Metabolic Diseases of the Department of Internal Medicine of the Friedrich-Schiller-University Jena
All patients with type 2 diabetes who failed to achieve their therapeutic goals under oral antidiabetic therapy and who were referred by local General Practitioners to the outpatient clinic for initiation of insulin therapy were candidates for inclusion in the study Participants who agreed to participate in the study were recruited in consecutive order as they were referred to the out-patient clinic They were not admitted to the study if any of the following criteria were present 1 not type 2 diabetes 2 diabetes duration 2 years 3 not insulin naive 4 ineffective oral antidiabetic therapy 3 months 5 GHb below 7 or above 11 6 age below 40 or above 65 years 7 co-medication with corticosteroids 8 pregnancy severe mental or somatic diseases or 9 unwillingness to return for follow-up
The primary end-point with respect to the effectiveness of FIT and CIT was glycosylated GHb Secondary end-points were mild and severe symptoms of hypoglycemia insulin dosage blood pressure BMI and individual therapy preference
Sample size To have a 90 chance of detecting as significant at the two sided 5 level a 05 difference between the two groups in GHb with an assumed standard deviation of 08 38 participants were required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None