Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392678
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2006-10-25
Brief Title:
Targeting INflammation Using SALsalate in Type 2 Diabetes TINSAL-T2D
Sponsor:
Joslin Diabetes Center
Organization:
Joslin Diabetes Center
Study Overview
Official Title:
Targeting Inflammation in Type 2 Diabetes Clinical Trial Using Salsalate
Status:
COMPLETED
Status Verified Date:
2019-03
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:
TINSAL-T2D
Brief Summary:
Growing evidence over recent years supports a potential role for low grade chronic inflammation in the pathogenesis of insulin resistance and type 2 diabetes In this study we will determine whether salsalate a member of the commonly used Non-Steroidal Anti-Inflammatory Drug NSAID class is effective in lowering sugars in patients with type 2 diabetes The study will determine whether salicylates represent a new pharmacological option for diabetes management The study is conducted in two stages The first stage is a dose ranging study administering salsalate compared to placebo over three months The primary objective of Stage 2 of the study is to evaluate the effects of salsalate on blood sugar control in diabetes the tolerability of salsalate use in patients with type 2 diabetes T2D and the effects of salsalate on measures of inflammation the metabolic syndrome and cardiac risk
The second stage is a second trial and posted under alternate registration
The second stage is a second trial and posted under alternate registration
Detailed Description:
The primary objective of the first stage of the TINSAL-T2D trial is to select a dose of salsalate that is both well-tolerated and demonstrates a trend toward improvement in glycemic control The trial is a multicenter single mask lead-in double masked placebo controlled dose ranging study comparing salsalte to placebo over 3 months
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 |
|---|---|---|---|
| U01DK074556 | NIH | None | httpsreporternihgovquickSearchU01DK074556 |