Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes

NCT01378117 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00048954a
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a multicenter, prospective, open-label, randomized pilot study to investigate the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2 diabetes (T2D) in general medicine and surgery patients.

Conditions

Type 2 Diabetes Mellitus; Hospitalization; Hyperglycemia

Keywords

diabetes; non critical care setting; hyperglycemia; treatment; oral antidiabetic agents; subcutaneous insulin

Outcome Measures

Primary Outcomes (1)

• Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy

  The primary outcome of the study is to determine differences in glycemic control as measured by mean BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with type 2 diabetes mellitus, at the time of admission to the blood glucose levels 24hrs after the therapy

  Admission and after 1st day of therapy

Secondary Outcomes (8)

• Number of Patients With Hypoglycemic Events Among the Treatment Groups

  during hospitalization,up to 10 days

• Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups

  during hospitalization,up to 5 days

• Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups

  during hospitalization,up to 10 days

• Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups

  during hospitalization, up to 10 days

• Mean Length of Stay in Days in the Hospital Among Different Groups

  during hospitalization, up to 10 days

Study Arms (3)

Sitagliptin + SSI prn

EXPERIMENTAL

Sitagliptin once daily plus supplemental doses of lispro if needed using sliding scale insulin (SSI). 100 mg/day (at any time of day) for patients with GFR 50-100 ml/min and 50 mg/day for patients with GFR 30-50 ml/min

Drug: Sitagliptin

Sitagliptin and glargine+ SSI

EXPERIMENTAL

Sitagliptin 50-100 mg per oral once a day and SubCutaneous (SQ) glargine insulin once daily + correctional doses of lispro if needed for elevated blood glucose using sliding scale insulin (SSI). 100 mg/day (at any time of day) for patients with glomerular filtration rate (GFR) 50-100 ml/min and 50 mg/day for patients with GFR 30-50 ml/min

Drug: glargine

Glargine and Lispro + SSI

ACTIVE COMPARATOR

Glargine once daily and lispro before meals supplemental insulin lispro as needed for elevated blood glucose using sliding scale insulin (SSI)

Drug: lispro

Interventions

Sitagliptin DRUG

Sitagliptin 50-100mg po once daily

Also known as: Januvia

Sitagliptin + SSI prn

glargine DRUG

glargine once daily

Also known as: Lantus (glargine)

Sitagliptin and glargine+ SSI

lispro DRUG

lispro before meals

Also known as: Humalog (lispro)

Glargine and Lispro + SSI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between the ages of 18 and 80 years admitted to a general medicine and surgery services.
• A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding Trazodone (TZDs) and DPP4 inhibitors), or low-dose (≤ 0.4 units/kg/day) insulin therapy.
• Subjects with a BG \>140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 milliequivalent /L or positive serum or urinary ketones).

You may not qualify if:

• Age \< 18 or \> 80 years.
• Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
• Subjects with a history of type 1 diabetes (suggested by BMI \< 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) \[46\].
• History of TZD treatment (pioglitazone or rosiglitazone) or DPP4 inhibitor (sitagliptin or saxagliptin) during the past 3 months prior to admission.
• Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require prolonged admission to a critical care unit (ICU, cardiac care unit , surgical intensive care unit, neuro ICU).
• Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
• Medical or surgical patients expected to be kept nil per os (NPO) for \>24-48 hours after admission or after completion of surgical procedure.
• Patients with clinically relevant pancreatic or gallbladder disease.
• Patients with congestive heart failure (NYHA class III and IV), acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (serum creatinine ≥ 2.0 mg/dL).
• Treatment with oral or injectable corticosteroid.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects are pregnant or breast feeding at time of enrollment into the study.

Sponsors & Collaborators

• Emory University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital

Atlanta, Georgia, 30324, United States

Location

Related Publications (1)

• Umpierrez GE, Gianchandani R, Smiley D, Jacobs S, Wesorick DH, Newton C, Farrokhi F, Peng L, Reyes D, Lathkar-Pradhan S, Pasquel F. Safety and efficacy of sitagliptin therapy for the inpatient management of general medicine and surgery patients with type 2 diabetes: a pilot, randomized, controlled study. Diabetes Care. 2013 Nov;36(11):3430-5. doi: 10.2337/dc13-0277. Epub 2013 Jul 22.

  PMID: 23877988 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Diabetes Mellitus

Interventions

Sitagliptin Phosphate; Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Limitations and Caveats

Study recruited a relatively small number of patients and excluded a large number of patients, which included those admitted to the ICU. Study was not powered to determine differences in hospital complications across the three groups

Results Point of Contact

• Title: Guillermo Umpierrez, MD
• Organization: EUSOM

geumpie@emory.edu

4047781665

Study Officials

• Guillermo Umpierrez, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Professor of Medicine

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: June 22, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 7, 2018
• Results First Posted: June 12, 2014

Record last verified: 2018-11

Locations

US (2)