Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194896
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2005-09-14
Brief Title:
Preferred Treatment of Type 15 Diabetes
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Rosiglitazone Intervention Study in Patients With Type 15 Diabetes
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
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:
The purpose of this research was to test whether one treatment was superior over another in the management of type 15 diabetes Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide
Detailed Description:
Type 1 diabetes and Type 2 diabetes have different underlying pathophysiologic processes The disease process in classical Type 1 diabetes is an autoimmune destruction of the pancreatic beta cells In contrast the disease process in classical Type 2 diabetes is not autoimmune in nature a decreased sensitivity to insulin action is central to the disease process and a poorly understood but non-inflammatory beta cell lesion occurs which diminishes insulin secretion In clinical practice the diagnosis of Type 1 versus Type 2 diabetes is made phenotypically using variables such as age at onset apparent abruptness of onset of hyperglycemia presence of ketosis degree of obesity especially central and intra abdominal prevalence of other autoimmune diseases and apparent need for insulin replacement This clinical distinction of Type 1 versus Type 2 diabetes is recognized to be imperfect
There is also a third group of individuals who phenotypically are usually like classic Type 2 diabetics but who are positive for one or more of the autoantibodies commonly seen in the Type 1 disease process namely islet cell antibodies ICA andor insulin autoantibodies IAA andor autoantibodies to glutamic acid decarboxylase GAD Ab andor autoantibodies to the tyrosine phosphatase islet cell autoantibody 512 IA 2 Ab
These patients autoantibody positive Ab Type 2 or Type 15 diabetes were the focus of our study Compared to antibody negative Type 2 diabetics patients with Type 15 diabetes have a more rapid decline in beta cell function fail sulfonylurea therapy and require insulin therapy earlier 4-13
Hypothesis Rosiglitazone treatment will ameliorate or slow the underlying disease process in antibody positive Type 2 diabetes
Patients meeting the inclusion criteria came in for a baseline visit The nature of the study was explained and informed consent obtained A fasting blood sample was obtained for autoantibodies glucose C peptide of proinsulin molecule C-peptide glycosylated hemoglobin HbA1c genetic typing and T lymphocyte T cell responses to islet antigens The beta cell function test was performed Patients were then randomized to either rosiglitazone or glyburide
All patients were encouraged to perform self blood glucose monitoring twice per day before breakfast and before dinner The treatment goals for all patients was the same before breakfast and before dinner blood sugar levels between 90-130 milligrams per deciliter mgdI and HbA1c of less then 7 without severe hypoglycemia Patients unable to reach goal with monotherapy had metformin initially or acarbose secondarily added as there is no evidence to suggest that either affect beta-cell function
The rosiglitazone treatment group commenced therapy with 4 milligram mg once per day and increased to twice per day if adequate glycemic control was not achieved For glyburide therapy was initiated with 25 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study The starting dose was raised by 25 mg in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control
If adequate control HbA1c less than 7 was not achieved on glyburide or rosiglitazone monotherapy metformin was added and the dose gradually increased as needed and tolerated to a maximum of 1000 mg twice daily If necessary acarbose was also used up to a maximum dose of 100 mg thrice daily as needed and tolerated
After initiation of the study patients were seen at 1 month and then every 3 months for up to 3 years Those patients randomized to rosiglitazone had the liver enzyme alanine transaminase ALT monitored every 2 months In addition telephone contact was utilized to achieve and maintain glycemic goals Each participant was followed for up to 3 years Drs Chiu and Palmer coordinated the study If the patient and hisher private physician prefer the treatment protocol was implemented by the patients private physician
There is also a third group of individuals who phenotypically are usually like classic Type 2 diabetics but who are positive for one or more of the autoantibodies commonly seen in the Type 1 disease process namely islet cell antibodies ICA andor insulin autoantibodies IAA andor autoantibodies to glutamic acid decarboxylase GAD Ab andor autoantibodies to the tyrosine phosphatase islet cell autoantibody 512 IA 2 Ab
These patients autoantibody positive Ab Type 2 or Type 15 diabetes were the focus of our study Compared to antibody negative Type 2 diabetics patients with Type 15 diabetes have a more rapid decline in beta cell function fail sulfonylurea therapy and require insulin therapy earlier 4-13
Hypothesis Rosiglitazone treatment will ameliorate or slow the underlying disease process in antibody positive Type 2 diabetes
Patients meeting the inclusion criteria came in for a baseline visit The nature of the study was explained and informed consent obtained A fasting blood sample was obtained for autoantibodies glucose C peptide of proinsulin molecule C-peptide glycosylated hemoglobin HbA1c genetic typing and T lymphocyte T cell responses to islet antigens The beta cell function test was performed Patients were then randomized to either rosiglitazone or glyburide
All patients were encouraged to perform self blood glucose monitoring twice per day before breakfast and before dinner The treatment goals for all patients was the same before breakfast and before dinner blood sugar levels between 90-130 milligrams per deciliter mgdI and HbA1c of less then 7 without severe hypoglycemia Patients unable to reach goal with monotherapy had metformin initially or acarbose secondarily added as there is no evidence to suggest that either affect beta-cell function
The rosiglitazone treatment group commenced therapy with 4 milligram mg once per day and increased to twice per day if adequate glycemic control was not achieved For glyburide therapy was initiated with 25 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study The starting dose was raised by 25 mg in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control
If adequate control HbA1c less than 7 was not achieved on glyburide or rosiglitazone monotherapy metformin was added and the dose gradually increased as needed and tolerated to a maximum of 1000 mg twice daily If necessary acarbose was also used up to a maximum dose of 100 mg thrice daily as needed and tolerated
After initiation of the study patients were seen at 1 month and then every 3 months for up to 3 years Those patients randomized to rosiglitazone had the liver enzyme alanine transaminase ALT monitored every 2 months In addition telephone contact was utilized to achieve and maintain glycemic goals Each participant was followed for up to 3 years Drs Chiu and Palmer coordinated the study If the patient and hisher private physician prefer the treatment protocol was implemented by the patients private physician
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 16707D | OTHER | University of Washington | None |
| 496539-188 | None | None | None |