Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D

NCT02607410 | Completed Phase 4

• 1 other identifier: MERS2015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin , with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide: effects on beta cell function and on metabolic profile.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes; sitagliptin; NPH insulin; GLP-1

Outcome Measures

Primary Outcomes (1)

• improvement in HbA1c levels

  Changes in fasting blood levels of HBA1c (%)

  six and twelve months

Secondary Outcomes (2)

• improvement of beta cell function with a meal test

  six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test

• improvement on alpha cell function with a meal test

  six and twelve months after each therapy at times zero, 30, 60, 120 and 180 minutes after meal test

Study Arms (2)

sitagliptin

ACTIVE COMPARATOR

100mg every day of sitagliptin in patients that were previosly using metformin and glyburide

Drug: sitagliptin

NPH insulin

ACTIVE COMPARATOR

NPH insulin will be applied bedtime every night in patients that awere previously using metformin and glyburide,The insulin dosage will be adjusted to fasting glycemia between 90 and 100 mg / dL

Drug: NPH insulin

Interventions

sitagliptin DRUG

patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year

Also known as: DPP-4 inhibitor

sitagliptin

NPH insulin DRUG

patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year

Also known as: long-acting insulin

NPH insulin

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients with T2D inadequately controlled with metformin plus glyburide
• HbA1c levels between 6.6 and 10%
• body mass index \< 35 kg/m2

You may not qualify if:

• heart failure
• respiratory failure
• uncontrolled hypertension
• impaired hepatic function
• impaired reanl function
• endocrine disorder
• gastrointestinal disorder
• malignancy
• alcohol abuse
• previous use of insulin
• previou use of based incretin therapy
• type 1 diabetes.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (3)

• Muscelli E, Casolaro A, Gastaldelli A, Mari A, Seghieri G, Astiarraga B, Chen Y, Alba M, Holst J, Ferrannini E. Mechanisms for the antihyperglycemic effect of sitagliptin in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Aug;97(8):2818-26. doi: 10.1210/jc.2012-1205. Epub 2012 Jun 8.

  PMID: 22685234 BACKGROUND

• Aulinger BA, Bedorf A, Kutscherauer G, de Heer J, Holst JJ, Goke B, Schirra J. Defining the role of GLP-1 in the enteroinsulinar axis in type 2 diabetes using DPP-4 inhibition and GLP-1 receptor blockade. Diabetes. 2014 Mar;63(3):1079-92. doi: 10.2337/db13-1455. Epub 2013 Dec 2.

  PMID: 24296715 BACKGROUND

• Retnakaran R, Qi Y, Opsteen C, Vivero E, Zinman B. Initial short-term intensive insulin therapy as a strategy for evaluating the preservation of beta-cell function with oral antidiabetic medications: a pilot study with sitagliptin. Diabetes Obes Metab. 2010 Oct;12(10):909-15. doi: 10.1111/j.1463-1326.2010.01254.x.

  PMID: 20920044 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; Dipeptidyl-Peptidase IV Inhibitors; Insulin, Isophane; Insulin, Long-Acting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maria ER Siva, MD, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 18, 2015
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2014
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

BR (1)