Type 2 DiabetesPhase 1/2NCT01396564
Pioglitazone and Metformin in Diabetic Children
A Phase 1/2 study testing Metformin and Pioglitazone in people with Type 2 Diabetes, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D). MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association (ADA) were included, not under… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin and Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2005to Jul 2011
- Phase
- Phase 1/2
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients with type 2 diabetes according to ADA.
- Patients who have not previously received anti-diabetic treatment or have been treated solely with diet and exercise or have received only one anti-diabetic agent, and who have not applied insulin within 1 month of study start.
- HbA1c between >6.5% and <10%.
- Stable body weight at least 3 months before study start.
- No intense exercise.
- Free of other infectious, chronic, or acute inflammatory processes in the 3 months prior to study.
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- Previous informed consent signed (both children and parents or guardians).
- Either sex
- 8-17 years old.
Who cannot join
- Personal history of type 1 diabetes
- Chronic renal failure or serum creatinine over 1.0 mg/dl.
- Active hepatic disease (ALT and AST 3 times normal)
- Heart conditions
- Acute or chronic metabolic acidosis
- Receiving steroids or insulin
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Endocrine Outpatient Clinic of the Hospital de Pediatria del CMN "Siglo XXI"
Mexico City, Mexico City, 06720
About this study
Official title: Comparison of the Effects of Pioglitazone and Metformin on Resistin Plasma Levels in Children With Type 2 Diabetes
HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D).
MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association (ADA) were included, not under treatment or who had been treated exclusively with diet and exercise or who only received an anti-diabetic agent, as well as those with a history of insulin use who had not applied insulin within 1 month before the initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin.
STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t test. Lineal or logarithmic regression analysis is used to evaluate the relationship between homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The statistical significance between variables is determined using ANOVA. The effect of confounding variables is analyzed with a test of co-variance analysis. Statistical significance is considered as p <0.05.
Read the detailed description
At 2 weeks prior to study all subjects meet with a dietician and are instructed to consume a weight-maintaining diet containing 50% carbohydrate, 30% fat, and 20% protein. During the week prior to the start of pioglitazone or metformin treatment, all subjects come to the clinic after a 12 hr overnight fast for a clinical examination (body weight, height, waist and hip circumferences) and biochemical tests. All tests are done between 8 and 10 am. A general structured interview is conducted. A questionnaire is used to obtain information on demographic and socioeconomic aspects. Anthropometric measurements are obtained. Body weight is measured on a 140-kg capacity floor scale, with the child standing in the center of the scale. Height is obtained by use of the floor scale's stadiometer, with the child standing in the center of the scale. Height is measured to the nearest 0.5 cm. Body weight is measured recorded to the nearest 0.1 Kg. Body Mass Index (BMI) is calculated as weight (Kg) divided by height (m2). Abdominal circumference is measured to the nearest 0.1 cm at the level of the greatest frontal extension of the abdomen between the bottom of the rib cage and the top of the iliac crest. The equipment is regularly calibrated using reference samples provided by the manufacturer. Baseline measurement of resistin (method) and insulin concentration (method). At the same time, blood samples are taken for liver function tests, fasting plasma glucose, lipids, and HbA1c.
All studies are performed at 08:00 h following a 10-12 h overnight fast. Following completion of these studies, subjects are randomized to start on pioglitazone or metformin, 15 mg/day and 850 mg respectively, for 4 weeks period, subjects return to the Clinical of Pediatric Endocrinology at 08:00 h, following an overnight fast, for measurement of fasting plasma glucose concentration, body weight, and blood pressure. Fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol) are measured . Fructosamine, HbA1c is measured during the initial and final week of pioglitazone or metformin treatment. Dietary adherence is reinforced. After 4 weeks of treatment, all subjects undergo a measurement of fasting plasma glucose, resistin, and insulin concentration.
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin, Pioglitazone
- Keywords
- Type 2 diabetes, Resistin, Inflammation, Insulin Resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Recommended diet and 30 minutes of exercise daily
850 mg of Metformin daily, increased to 1700 mg after 12 weeks, for the duration of the trial.
PioglitazoneDrug
Also called Recommended diet and 30 minutes of exercise daily
15 mg of pioglitazone daily, increased to 60 mg after 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Randomized patients are given 850 mg of metformin daily, increased to 1700 mg after 12 weeks. Adherence is evaluated and after the first phase, the arm is opened. Fasting plasma glucose concentration, body weight, and blood pressure, fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol), HbA1c are measured during the initial and final week of treatment. Dietary adherence is reinforced. Receives: Drug: Metformin |
| Pioglitazone | Active comparator | Randomized patients are given 15 mg of pioglitazone daily, increased to 60 mg after 12 weeks. Adherence is evaluated and after the first phase, the arm is opened. Fasting plasma glucose concentration, body weight, and blood pressure, fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol), HbA1c are measured during the initial and final week of treatment. Dietary adherence is reinforced. Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term comparison of metformin and pioglitazone in pediatric patients with T2D
To compare the effectiveness of metformin vs pioglitazone in children with T2D, in terms of resistin levels and insulin resistance. Compare various markers such as HbA1c,fasting plasma glucose, lipids, and hepatic function.
Measured: 48 weeks
Secondary outcomes (1)
Comparison of long-term effects of metformin vs pioglitazone
To compare the effectiveness of metformin vs pioglitazone in children with T2D, in terms of resistin levels and insulin resistance. Compare various markers such as HbA1c,fasting plasma glucose, lipids, and hepatic function over the long-term, as well as any secondary effects.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startOct 2005
- Primary completionOct 2006
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Investigators
- Niels H Wachter, DMSC, Study director, Supervisor Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396564
- Sponsor's protocol ID
- 2005-3606-0003
- Status last verified
- Jan 2005
- First submitted
- 15 Jul 2011
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Pioglitazone and Metformin on Resistin Plasma Levels in Children With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01396564
- Acronym / sponsor ID
- 2005-3606-0003
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Resistin, Inflammation, Insulin Resistance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Oct 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HYPOTHESIS: Treatment with pioglitazone is more effective in reducing resistin concentrations and insulin resistance than metformin in children with Type 2 Diabetes (T2D).
MATERIAL AND METHODS: Pediatric patients aged 8-17 with T2D as defined by the American Diabetes Association (ADA) were included, not under treatment or who had been treated exclusively with diet and exercise or who only received an anti-diabetic agent, as well as those with a history of insulin use who had not applied insulin within 1 month before the initial visit. History of T2D, hypertension, exercise, diet, age, gender and somatometry are recorded. A Blood sample is taken to determine HbA1c, glucose, insulin and resistin.
STATISTICAL ANALYSIS: The percentual change over 4 weeks is analyzed for concentrations of resistin, insulin resistance. Changes are noted for weeks 12, 24, 36 and 48 for resistin concentrations, HbA1c and HOMA values. Baseline and final values are compared with a paired t test. Lineal or logarithmic regression analysis is used to evaluate the relationship between homeostasis model assessment of insulin resistance (HOMA-IR) and resistin concentrations. The statistical significance between variables is determined using ANOVA. The effect of confounding variables is analyzed with a test of co-variance analysis. Statistical significance is considered as p <0.05.
Detailed description
At 2 weeks prior to study all subjects meet with a dietician and are instructed to consume a weight-maintaining diet containing 50% carbohydrate, 30% fat, and 20% protein. During the week prior to the start of pioglitazone or metformin treatment, all subjects come to the clinic after a 12 hr overnight fast for a clinical examination (body weight, height, waist and hip circumferences) and biochemical tests. All tests are done between 8 and 10 am. A general structured interview is conducted. A questionnaire is used to obtain information on demographic and socioeconomic aspects. Anthropometric measurements are obtained. Body weight is measured on a 140-kg capacity floor scale, with the child standing in the center of the scale. Height is obtained by use of the floor scale's stadiometer, with the child standing in the center of the scale. Height is measured to the nearest 0.5 cm. Body weight is measured recorded to the nearest 0.1 Kg. Body Mass Index (BMI) is calculated as weight (Kg) divided by height (m2). Abdominal circumference is measured to the nearest 0.1 cm at the level of the greatest frontal extension of the abdomen between the bottom of the rib cage and the top of the iliac crest. The equipment is regularly calibrated using reference samples provided by the manufacturer. Baseline measurement of resistin (method) and insulin concentration (method). At the same time, blood samples are taken for liver function tests, fasting plasma glucose, lipids, and HbA1c.
All studies are performed at 08:00 h following a 10-12 h overnight fast. Following completion of these studies, subjects are randomized to start on pioglitazone or metformin, 15 mg/day and 850 mg respectively, for 4 weeks period, subjects return to the Clinical of Pediatric Endocrinology at 08:00 h, following an overnight fast, for measurement of fasting plasma glucose concentration, body weight, and blood pressure. Fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol) are measured . Fructosamine, HbA1c is measured during the initial and final week of pioglitazone or metformin treatment. Dietary adherence is reinforced. After 4 weeks of treatment, all subjects undergo a measurement of fasting plasma glucose, resistin, and insulin concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminRandomized patients are given 850 mg of metformin daily, increased to 1700 mg after 12 weeks. Adherence is evaluated and after the first phase, the arm is opened. Fasting plasma glucose concentration, body weight, and blood pressure, fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol), HbA1c are measured during the initial and final week of treatment. Dietary adherence is reinforced. |
| Pioglitazone | Active comparator | Drug: PioglitazoneRandomized patients are given 15 mg of pioglitazone daily, increased to 60 mg after 12 weeks. Adherence is evaluated and after the first phase, the arm is opened. Fasting plasma glucose concentration, body weight, and blood pressure, fasting plasma lipids (total cholesterol, triglyceride, HDL cholesterol, and LDL cholesterol), HbA1c are measured during the initial and final week of treatment. Dietary adherence is reinforced. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Pediatric patients with type 2 diabetes according to ADA.
- Patients who have not previously received anti-diabetic treatment or have been treated solely with diet and exercise or have received only one anti-diabetic agent, and who have not applied insulin within 1 month of study start.
- HbA1c between >6.5% and <10%.
- Stable body weight at least 3 months before study start.
- No intense exercise.
Key exclusion criteria (6 listed)
- Personal history of type 1 diabetes
- Chronic renal failure or serum creatinine over 1.0 mg/dl.
- Active hepatic disease (ALT and AST 3 times normal)
- Heart conditions
- Acute or chronic metabolic acidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Recommended diet and 30 minutes of exercise daily850 mg of Metformin daily, increased to 1700 mg after 12 weeks, for the duration of the trial. | Drug | Metformin |
| PioglitazoneAlso: Recommended diet and 30 minutes of exercise daily15 mg of pioglitazone daily, increased to 60 mg after 12 weeks. | Drug | Pioglitazone |
Primary outcome
Short-term comparison of metformin and pioglitazone in pediatric patients with T2D
Time frame: 48 weeks
To compare the effectiveness of metformin vs pioglitazone in children with T2D, in terms of resistin levels and insulin resistance. Compare various markers such as HbA1c,fasting plasma glucose, lipids, and hepatic function.
1 secondary outcome
Comparison of long-term effects of metformin vs pioglitazone
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels H Wachter, DMSC study director
Supervisor Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Metformin and Pioglitazone in people with Type 2 Diabetes, run by Coordinación de Investigación en Salud, Mexico 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 6 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 19 Jul 2011. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Short-term comparison of metformin and pioglitazone in pediatric patients with T2D (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2011.