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Diabetes Type 2NCT00881543

"Effect of Dipeptidyl Peptidase IV After Diets in näive Type 2 Diabetic Patients"

A study testing Dipeptidyl Peptidase IV inhibitors in people with Diabetes Type 2, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat, protein and carbohydrate food) in drug näive tipo 2 patients. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Diabetes Type 2
What is being tested?
Dipeptidyl Peptidase IV inhibitors
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteBrazil
Study dates
Jun 2009to Oct 2011
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Drug näive patients with T2DM (for the purpose of this study "drug näive" patients are defined as subjects who have never been treated with an oral antidiabetic agent or subjects who have not taken any antidiabetic agent for at least 12 weeks prior to study entry (Visit 1) and if they had never received antidiabetic agents then never for > 3 months at any time in the past).
  • Age in the range of 18 - 78 years inclusive.
  • Male, non-fertile female or female of childbearing potential using a medically approved birth control method. A non-fertile female is defined as:
  • post menopausal ( 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40mlU/m)
  • 6 weeks post bilateral oophorectomy with or without hysterectomy
  • post hysterectomy
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  • or sterilized by tubal ligation.
  • Written informed consent to participate in the study.
  • Ability to comply with all study requirements.

Who cannot join

  • Pregnant or lactating female
  • A history of type 1 diabetes, diabetes that is result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing´s syndrome and acromegaly, acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
  • Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
  • Acute infections wich may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
  • Any of the following within the past 6 months:
  • myocardial infarction (MI) (if the visit one ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor)
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  • coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke.
  • Congestive heart failure (CHF) requiring pharmacological treatment.
  • Any of the following EGC abnormalities; "Torsades de points", sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree AV block (Mobitz 1 and 2 ), third degree AV block, prolonged QTc (>500 msec)
  • Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
  • Liver disease such as cirrhosis or chronic active hepatitis.
  • Donation of one unit ( 500ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
  • Chronic insulin (>4 weeks of treatment in the absence of an intercurrent illness) within the past 6 month.
  • Chronic oral or parenteral corticosteroid treatment ( > 7 consecutive days of treatment) within 8 weeks prior to visit 1.
  • Treatment with growth hormone or similar drugs.
  • Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
  • Patients who have already been in a study of sitagliptin or another DPP 4 inhibitor.
  • Use of other investigational drugs at visit 1, or within 30 days or 5 half-lives of visit 1.
  • Any of the following significant laboratory abnormalities:
  • ALT, AST greater than 3 times the upper limit of the normal range at visit 1. *clinically significant renal dysfunction as indicated by serum creatinine levels > or equal 1,5mg/dl in males, > or equal 1,4 mg/dl in females, or a history of abnormal creatinine clearance < 60 ml/m2/24h
  • clinically significant TSH values outside of normal range at visit 1
  • clinically significant laboratory abnormalities, confirmed by repeated measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1.
  • fasting triglycerides > 700 mg / dl at visit 1.
  • History of active substance abuse (including alcohol) within the past 2 years.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of São Paulo General Hospital

    São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: "Effect of Dipeptidyl Peptidase IV Inhibitors on Glycemia, Insulin, Glucagon, C Peptide, Glp 1 and Lipids After Isocaloric Meals With Different Nutritional Composition in Patients With Type 2 Diabetes näive of Treatment"

The purpose of this study is to demonstrate the secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets with different nutritional compounds (fat, protein and carbohydrate food) in drug näive tipo 2 patients.

Read the detailed description

It is well known that there is a progressive deterioration in beta-cell function over time in type 2 diabetes (DM2), as indicated by the UKPDS (United Kingdom Prospective Diabetes Study), regardless of therapy allocation, albeit conventional (mainly diet), insulin, chlorpropamide, glibenclamide or metformin treatment. Moreover, the pancreatic islet function was found to be about 50% of normal at the time of diagnosis, independent of the degree of insulin resistance, with the reduction in function probably commencing 10-12 years prior to diagnosis and aggravated by increasing fasting plasma glucose levels.

Optimal metabolic control, especially early intensive glycemic control, plays a role in the prevention of progressive beta cell dysfunction and possibly destruction of the betacells with worsening of diabetes. Many reports have shown that induction of normoglycemia in DM2 results in both improved beta cell function and insulin resistance.The major therapeutic drawback using native GLP-1 is its very short half-life of less than 2 minutes, following exogenous administration, as previously indicated due in part to the protease DDP-IV a result, preventing the degradation of native GLP-1 by inhibiting the active of the DDP-IV enzyme has emerged as a therapeutic strategy for enhancing endogenous GLP-1 action in vivo.Considering that, sitagliptin is the first FDA and ANVISA authorized dipeptidyl peptidase-IV (DPP-IV) inhibitor for diabetes treatment and considering the lack of data about DPP-IV inhibitor effect over glucose, glucagon, insulin, C -peptide and fats after isocaloric diets with different nutritional composition in drug näive patients with type 2 diabetes, we designed this study.

Conditions
Diabetes Type 2
Being tested
Dipeptidyl Peptidase IV inhibitors
Keywords
Sitagliptin, Diets, Diabetes type 2, Näive patients
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.

  • Dipeptidyl Peptidase IV inhibitorsDrug

    Also called Januvia (Merck Sharp Dome), Sitagliptin

    Dosage 100 mg each day, once a day, 2 months

Study groups in NCT00881543
Study groupRoleWhat they receive
1Placebo comparatorThis arm will begin taking the placebo by a month, after a month will be tested the diets (the same caloric amount with different composition on fat, protein and carbohydrates)making curves of insulin, glucagon, C peptide and glp 1 and lipid when diets are tested (three acute tests with diets). After that, the patient will begin the drug by month (Januvia, 100 mg a day)and repeat all the three curves using the prepared diets to compare with the first month.
Receives: Drug: Dipeptidyl Peptidase IV inhibitors
2Active comparatorSince the beginning they will use the drug. Then will make the three tests and after will stop the drug by 1 month and come back to do the tests. We objective to demonstrate the washout of the drug clinically.
Receives: Drug: Dipeptidyl Peptidase IV inhibitors

What is being measured

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

  1. secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets

    Measured: One month

Secondary outcomes (1)

  1. Washout of dipeptidyl peptidase IV inhibitors after one month without the drug

    Measured: One month

Timeline

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

  1. First posted15 Apr 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2010
  4. Study completionOct 2011

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00881543
Sponsor's protocol ID
USaoPauloGH
Status last verified
May 2012
First submitted
14 Apr 2009
Last updated
28 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • da Silva Schreiber C, Rafacho A, Silverio R, Betti R, Lerario AC, Lotenberg AMP, Rahmann K, de Oliveira CP, Wajchenberg BL, da Luz PL. The effects of macronutrients composition on hormones and substrates during a meal tolerance test in drugnaive and sitagliptin-treated individuals with type 2 diabetes: a randomized crossover study. Arch Endocrinol Metab. 2022 May 13;66(3):312-323. doi: 10.20945/2359-3997000000478. Epub 2022 May 12.

    PubMed 35551683

Questions about this trial

What is this clinical trial studying?

A study testing Dipeptidyl Peptidase IV inhibitors in people with Diabetes Type 2, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 24 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 28 May 2012. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

secretion of glucose, insulin, glucagon, C-peptide and lipid profile after isocaloric diets (time frame: One month). 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 NCT00881543, which also lists 1 linked publication.

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 28 May 2012.

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