Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit

NCT02250794 | Withdrawn Phase 4

• 1 other identifier: 14042807
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test whether a combination of two pills commonly used to treat outpatient diabetes called metformin and sitagliptin (januvia) could provide successful control of blood sugar levels in patients with type 2 diabetes during hospitalization for the treatment of a general medical condition. Both metformin and sitagliptin are currently approved by the Food and Drug Administration for the treatment of type 2 diabetes, but little experience exists for their use in hospitalized patients. The current standard practice is to use insulin injections to control blood sugar in hospitalized patients with type 2 diabetes. This study will compare the use of metformin tablets twice per day along with sitagliptin tablets once per day with daily insulin injections in patients with type 2 diabetes during hospitalization, and will study how well the blood sugar levels are controlled.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes mellitus; inpatient management; metformin; sitagliptin

Outcome Measures

Primary Outcomes (1)

• mean blood glucose for the duration of the hospital stay

  Participants will be followed for the duration of the hospital stay, an expected average of 5 days.

  duration of hospital stay

Secondary Outcomes (1)

• frequency of hypoglycemia

  duration of hospital stay

Other Outcomes (1)

• Acute kidney injury

  duration of hospital stay

Study Arms (2)

insulin glargine and insulin lispro

ACTIVE COMPARATOR

insulin glargine 0.3 units per kg and insulin lispro 0.1 units per kg with each meal

Drug: insulin glargine and insulin lispro

metformin and sitagliptin

EXPERIMENTAL

metformin 750 mg PO twice daily and sitagliptin 100 mg PO once daily

Drug: metformin and sitagliptin

Interventions

metformin and sitagliptin DRUG

metformin 750 mg PO twice daily

Also known as: glucophage

metformin and sitagliptin

insulin glargine and insulin lispro DRUG

insulin glargine given once daily

Also known as: lantus insulin

insulin glargine and insulin lispro

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 services not requiring intensive care and not expected to require surgery.
• Type 2 diabetes for ≥ 3 months treated with metformin (≥ 1000 mg/day) alone or metformin (≥ 1000 mg/day) with glimepiride, glyburide, glipizide, saxagliptin, sitagliptin, linagliptin, alogliptin, repaglinide, nateglinide, pioglitazone, exenatide, liraglutide, or a total daily dose of insulin ≤ 0.4 units/kg/day prior to admission.
• Blood glucose\>140 mg and \< 400 mg/dL

You may not qualify if:

• Acute critical illness expected to require admission to a critical care unit
• Patients expected to require major surgery (requiring general anesthesia)
• Patients expected to require gastrointestinal suction
• Patients treated with less than 1000 mg/day of metformin prior to admission
• Patients expected to be kept nothing by mouth (NPO) for \>24-48 hours after admission
• Patients with impaired renal function estimated GFR less than 60 ml/min based on the Modification of Diet in Renal Disease (MDRD) Study equation.
• Clinically significant liver dysfunction or current alcohol abuse
• Uncompensated heart failure
• Myocardial or peripheral muscle ischemia
• Sepsis or severe infection
• Treatment with glucocorticoid greater than prednisone 5 mg daily or the equivalent
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Pregnancy or breast-feeding at time of enrollment into the study

Sponsors & Collaborators

• Rush University Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Sitagliptin Phosphate, Metformin Hydrochloride Drug Combination; Metformin; Insulin Glargine; Insulin Lispro; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Drug Combinations; Pharmaceutical Preparations; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 26, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 11, 2021

Record last verified: 2021-10