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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02250794
Recruitment Status : Unknown
Verified July 2014 by Rush University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: metformin and sitagliptin Drug: insulin glargine and insulin lispro Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015


Arm Intervention/treatment
Active Comparator: insulin glargine and insulin lispro
insulin glargine 0.3 units per kg and insulin lispro 0.1 units per kg with each meal
Drug: insulin glargine and insulin lispro
insulin glargine given once daily
Other Name: lantus insulin

Drug: insulin glargine and insulin lispro
insulin lispro given three times daily with meals
Other Name: humalog insulin

Experimental: metformin and sitagliptin
metformin 750 mg PO twice daily and sitagliptin 100 mg PO once daily
Drug: metformin and sitagliptin
metformin 750 mg PO twice daily
Other Name: glucophage

Drug: metformin and sitagliptin
sitagliptin 100 mg PO once daily
Other Name: Januvia




Primary Outcome Measures :
  1. mean blood glucose for the duration of the hospital stay [ Time Frame: duration of hospital stay ]
    Participants will be followed for the duration of the hospital stay, an expected average of 5 days.


Secondary Outcome Measures :
  1. frequency of hypoglycemia [ Time Frame: duration of hospital stay ]
    Participants will be followed for the duration of the hospital stay, an expected average of 5 days. The outcome is the percent of patients having any blood glucose value less than 70 mg/dl during their hospital stay.


Other Outcome Measures:
  1. Acute kidney injury [ Time Frame: duration of hospital stay ]
    Participants will be followed for the duration of the hospital stay, an expected average of 5 days. The outcome is the percent of patients who develop acute kidney injury during their hospital stay. Acute kidney injury is defined as an absolute increase in the serum creatinine concentration of ≥ 0.3 mg/dL from baseline or a percentage increase in the serum creatinine concentration of ≥ 50%



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Blood glucose>140 mg and < 400 mg/dL

Exclusion Criteria:

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250794


Contacts
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Contact: David Baldwin, MD 312 942 6163 david_baldwin@rush.edu
Contact: Jill Apel, MD 312 942-5000 ext page 3309 jill_f_apel@rush.edu

Sponsors and Collaborators
Rush University Medical Center
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02250794    
Other Study ID Numbers: 14042807
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: July 2014
Keywords provided by Rush University Medical Center:
diabetes mellitus
inpatient management
metformin
sitagliptin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Sitagliptin Phosphate
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action