C-peptide Concentrations in Type 2 Diabetes Treated With Insulin; is it Time to Revise the Treatment of Type 2 Diabetes

Type 2 Diabetes Treated With Insulin Clinical Trial

Official title:

Is it Time to Revise Type 2 Diabetes Treatment: C-peptide Concentrations in Type 2 Diabetes Treated With Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005261
• Other study ID #: C-peptide2019
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2019
• Source: Goztepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

C-peptide is used to evaluate beta cell reserves. Patients with type 2 diabetes are treated with insulin for different indications. Other than beta-cell insufficiency and organ failures, insulin treatment is needed for a specified period. The investigators want to evaluate beta cell reserves in patients with type 2 diabetes treated with insulin for at least six months to see if that is the case. The investigators also want to compare the characteristics of these patients according to their beta cell reserves.

Description:

In patients with type 2 diabetes, initiation of insulin therapy is indicated in several conditions such as severe insulin resistance, acute metabolic decompensations, surgery, pregnancy, and progression of diabetic complications, and also when glycemic control cannot be achieved with effective lifestyle regulation and non-insulin antidiabetic medications. Some of these indications are transient, and patients should be reassessed to choose the appropriate treatment options. Clinical inertia is one of the new topics expressed in the recent diabetes guidelines. The investigators aimed to investigate the beta cell reserves of the patients with type 2 diabetes who are treated with insulin, to see if they have insufficient insulin secretion and if not, to compare their characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes who had been treated with insulin as a monotherapy or as a component of combination therapy for at least 6 months.

Exclusion Criteria:

• Diagnosis of other types of diabetes,

• end-stage renal failure,

• history of renal transplantation,

• diabetic acute metabolic decompensation,

• decompensated heart failure,

• advanced liver disease,

• pregnancy,

• acute or chronic pancreatitis,

• pancreatic carcinoma,

• acute infections,

• use of medications that might affect glucose regulation (e.g. corticosteroids)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

Diagnostic Test:
• C-peptide concentrations
The patients will be grouped by their C-peptide concentrations

Locations

Country	Name	City	State
Turkey	IMU Goztepe Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S90-S102. doi: 10.2337/dc19-S009. Review. — View Citation

Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract. 2019 Jan;25(1):69-100. doi: 10.4158/CS-2018-0535. Erratum in: Endocr Pract. 2019 Feb;25(2):204. — View Citation

Jones AG, Hattersley AT. The clinical utility of C-peptide measurement in the care of patients with diabetes. Diabet Med. 2013 Jul;30(7):803-17. doi: 10.1111/dme.12159. Review. — View Citation

Leighton E, Sainsbury CA, Jones GC. A Practical Review of C-Peptide Testing in Diabetes. Diabetes Ther. 2017 Jun;8(3):475-487. doi: 10.1007/s13300-017-0265-4. Epub 2017 May 8. Review. — View Citation

Palmer JP, Fleming GA, Greenbaum CJ, Herold KC, Jansa LD, Kolb H, Lachin JM, Polonsky KS, Pozzilli P, Skyler JS, Steffes MW. C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21-22 October 2001. Diabetes. 2004 Jan;53(1):250-64. Erratum in: Diabetes. 2004 Jul;53(7):1934. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adequate, borderline and insufficient beta cell reserves assessed by the fasting C-peptide concentrations	Fasting C-peptide concentrations will be measured in patients with type 2 diabetic patients using insulin as a monotherapy or as part of combination therapy and the patients will be grouped as patients with adequate beta cell reserves, patients with borderline beta cell reserves and patient with insufficient beta cell reserves.	3 months
Primary	Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings	Correlations of fasting C-peptide concentrations with patients characteristics and biochemical findings, especially the components of metabolic syndrome.	3 months