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Type 2 Diabetes MellitusPhase 4NCT00941161

Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing metformin/glimepiride combination, metformin and glimepiride in people with Type 2 Diabetes Mellitus, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
metformin/glimepiride combination, metformin and glimepiride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteMexico
Study dates
Feb 2009to May 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 40 to 65 years old
  • Ability to communicate and to meet the requirements of the study
  • Signed Written Informed Consent before to conducting any study
  • Body Mass Index (BMI) = 25-40kg/m2
  • Stable weight in the past three months (variability <5%)
  • Meal plan and monotherapy with oral hypoglycaemic fails
Show all 9Show fewer
  • Fasting glucose = 130-270 mg/dL
  • HbA1c > 7%
  • isocaloric diet with a minimum of 250 grams of carbohydrates per day in the three days prior to making the laboratory tests

Who cannot join

  • Suspected or confirmed pregnancy
  • Nursing
  • Inability to secure the non-pregnant during the study duration
  • Hypersensitivity to any of the drugs under study
  • Treatment with oral hypoglycemic or insulin
  • Consumption of substance with toxic effects on any organ system
Show all 10Show fewer
  • Liver failure, heart failure, kidney failure or thyroid disease
  • Chronic intake of alcohol
  • Periods of acute or chronic diarrhea or vomiting
  • Consumption of antifungal azoles, MAO inhibitors, nifedipine,furosemide, amiloride, digoxin, procainamide, quinidine, quinine, triamterene and vancomycin

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

    Guadalajara, Jalisco

Other trials in Mexico

About this study

Official title: Effect of Oral Combination Therapy of Metformin Extended Release Over Glimepiride in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus With Failure of Monotherapy

The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure.

Read the detailed description

A randomized double-blind clinical trial, to determine the effect of combined therapy of oral prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c. Patients will be included in this study are patients with diabetes mellitus and secondary failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin secretion. We evaluate the clinical measurements, laboratory and safety during 3 months, through the allocation of subjects to three study groups (metformin, glimepiride and metformin extended release / glimepiride)

Being tested
metformin/glimepiride combination, metformin, glimepiride
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metformin/glimepiride combinationDrug

    long acting metformin/glimepiride 1g/2mg

  • metforminDrug

    long acting metformin 1g once a day with fasting glucose 130-199mg/dL or long actin metformin 1g twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL

  • glimepirideDrug

    glimepiride 2mg once a day with fasting glucose 130-199mg/dL, or glimepiride 2mg twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL

Study groups in NCT00941161
Study groupRoleWhat they receive
combinationExperimentallong acting Metformin/Glimepiride
Receives: Drug: metformin/glimepiride combination
metforminActive comparatormetformin hydrocloride
Receives: Drug: metformin
glimepirideActive comparatorglimepiride
Receives: Drug: glimepiride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fasting glucose, HbA1c

    Measured: three months

Secondary outcomes (1)

  1. total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00941161
Sponsor's protocol ID
DMGlime-04
Status last verified
May 2010
First submitted
15 Jul 2009
Last updated
18 May 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • International Diabetes Federation / International Association for the Study of Obesity. Diabetes and Obesity 11-21, 2004

  • Grundy SM, Pasternak R, Greenland P, Smith S Jr, Fuster V. AHA/ACC scientific statement: Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology. J Am Coll Cardiol. 1999 Oct;34(4):1348-59. doi: 10.1016/s0735-1097(99)00387-3. No abstract available.

    PubMed 10520820

  • Tseng KH. Standards of medical care in diabetes--2006: response to the American Diabetes Association. Diabetes Care. 2006 Nov;29(11):2563-4; author reply 2564-5. doi: 10.2337/dc06-0805. No abstract available.

    PubMed 17065711

  • Cohen J, Colman P. Type 2 diabetes--the pharmacotherapy of glycaemic control and risk factor modification. Aust Fam Physician. 2006 Jun;35(6):380-4.

    PubMed 16751851

  • Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B; Professional Practice Committee, American Diabetes Association; European Association for the Study of Diabetes. Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2006 Aug;49(8):1711-21. doi: 10.1007/s00125-006-0316-2. No abstract available.

    PubMed 16802130

  • Riddle M. Combining sulfonylureas and other oral agents. Am J Med. 2000 Apr 17;108 Suppl 6a:15S-22S. doi: 10.1016/s0002-9343(00)00338-7.

    PubMed 10764846

  • Bermudez-Pirela VJ, Cano C, Medina MT, Souki A, Lemus MA, Leal EM, Seyfi HA, Cano R, Ciscek A, Bermudez-Arias F, Contreras F, Israili ZH, Hernandez-Hernandez R, Valasco M. Metformin plus low-dose glimeperide significantly improves Homeostasis Model Assessment for insulin resistance (HOMA(IR)) and beta-cell function (HOMA(beta-cell)) without hyperinsulinemia in patients with type 2 diabetes mellitus. Am J Ther. 2007 Mar-Apr;14(2):194-202. doi: 10.1097/01.pap.0000249909.54047.0e.

    PubMed 17414590

  • Gonzalez-Ortiz M, Martinez-Abundis E; Grupo para el Tratamiento de la Diabetes Mellitus con Combinaciones. [Efficacy and safety of glimepiride plus metformin in a single presentation, as combined therapy, in patients with type 2 diabetes mellitus and secondary failure to glibenclamide, as monotherapy]. Rev Invest Clin. 2004 May-Jun;56(3):327-33. Spanish.

    PubMed 15612515

  • Mandal U, Gowda V, Ghosh A, Selvan S, Solomon S, Pal TK. Formulation and optimization of sustained release matrix tablet of metformin HCl 500 mg using response surface methodology. Yakugaku Zasshi. 2007 Aug;127(8):1281-90. doi: 10.1248/yakushi.127.1281.

    PubMed 17666882

  • Schwartz S, Fonseca V, Berner B, Cramer M, Chiang YK, Lewin A. Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with type 2 diabetes. Diabetes Care. 2006 Apr;29(4):759-64. doi: 10.2337/diacare.29.04.06.dc05-1967.

    PubMed 16567811

  • Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.

    PubMed 8569826

  • McCall AL. Clinical review of glimepiride. Expert Opin Pharmacother. 2001 Apr;2(4):699-713. doi: 10.1517/14656566.2.4.699.

    PubMed 11336617

  • Schneider J. An overview of the safety and tolerance of glimepiride. Horm Metab Res. 1996 Sep;28(9):413-8. doi: 10.1055/s-2007-979829.

    PubMed 8911975

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metformin/glimepiride combination, metformin and glimepiride in people with Type 2 Diabetes Mellitus, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fasting glucose, HbA1c (time frame: three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00941161, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2010.

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