DiabetesNCT00596427
Mechanisms of Glucose Lowering Effect of Colesevelam HCl
A study testing Colesevelam HCL in people with Diabetes, run by Carine Beysen at 3 sites in United States.
Trial summary
The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the potential mechanism of action is important for defining the role of the drug among oral antidiabetic agents available for use in subjects with diabetes. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Colesevelam HCL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the trial:
- Have given written informed consent
- Male or Female
- Females of childbearing potential who are on approved birth control method:
- oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide or female condom plus spermicide
- Females of non-childbearing potential: hysterectomy, tubal ligation 6 months prior screening or post-menopausal for at least 1 year
Show all 16Show fewer
- Previously diagnosed or newly diagnosed with T2DM
- Age 30 to 70 years, inclusive
- BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2
- HbA1C 7-10%, inclusive (exceptions between 6.7-7% may be enrolled with prior approval of SPONSOR)
- Fasting plasma glucose < 300 mg/dL
- Diet controlled or on stable dose of a sulfonylurea and/or meglitinides and/or metformin for ≥ 90 days before screening
- No history of liver, biliary or intestinal disease (AST/ALT < 2X upper limit of normal value)
- Normal TSH
- Agrees to maintain their regular diet and exercise routine
- Agrees to refrain from consumption of alcohol 48 hours prior to start of infusions (week 0 and week 12)
Who cannot join
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Treatment with lipid lowering medication other than statins
- Treatment with statins that have not been stable for 3 months before screening
- Treatment with colesevelam HCl, cholestyramine or colestipol for hyperlipidemia within the last 3 months of screening
- Treatment with a thiazolidinedione (TZD) at any time
Show all 22Show fewer
- Treatment with acarbose at any time
- Treatment with insulin in the past 6 months
- Treatment with antibiotics within the last 3 months
- Treatment with any medication affecting liver or intestinal function within the last 3 months
- Pregnant
- Breastfeeding
- Has had unstable weight within the last 3 months of screening (± 5 kg)
- History of an allergic or toxic reaction to colesevelam HCl
- History of dysphagia, swallowing disorders, or intestinal motility disorder
- Serum triglycerides ≥ 350 mg/dL at screening visit (exceptions up to 500 mg/dl may be enrolled with prior approval of SPONSOR)
- Serum LDL-C <60 mg/dL at screening visit
- Any condition or therapy which, in the opinion of the investigator, poses a risk to the subject or makes participation not in the subject's best interest
- Use of any investigational drug within 3 months of screening
- Chronic treatment with oral corticosteroids at any time or acute treatment within the last 3 months
- History of drug or alcohol abuse, is currently a user (including "recreational use") of any illicit drugs, or has a positive urine drug screen at screening
- Donated a unit of blood within 30 days before screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Pharmacology of Miami, Inc
Miami, Florida, 33014
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, 78229
Diablo Clinical Research, Inc
Walnut Creek, California, 94598
About this study
Official title: Effects of Colesevelam HCl on Hepatic Insulin Sensitivity, Gluconeogenesis, Glucose Absorption and Lipid Synthesis in Subjects With Type 2 Diabetes Mellitus
The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the potential mechanism of action is important for defining the role of the drug among oral antidiabetic agents available for use in subjects with diabetes. The objective of this study is to provide insight into the mechanisms of action of colesevelam HCl in T2DM. The mechanisms of interest include hepatic insulin sensitivity, rate of appearance of exogenous glucose and changes in incretin hormone concentrations.
Read the detailed description
Colesevelam HCl (marketed in the U.S. as WelChol®) is a non-absorbed polymer that binds bile acids in the intestine, impeding their reabsorption, and is indicated to lower low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia. As the bile acid pool becomes depleted, the hepatic enzyme cholesterol 7-(alpha)-hydroxylase is upregulated, increasing the conversion of cholesterol to bile acids. This causes an increased demand for cholesterol in the liver, resulting in the dual effect of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase, and increasing the number of hepatic low-density lipoprotein (LDL) receptors. These compensatory effects increase the clearance of LDL-C from the blood, decreasing serum LDL C levels (1; 2).
Recently, it has been shown that colesevelam HCl also improves glycemic control in subjects with T2DM who are not controlled adequately on metformin, sulfonylurea or a combination of the two drugs (3). The mechanism of action for glucose lowering is not known. Improved glycemic control with colesevelam HCl treatment could be due to any of several mechanisms. Colesevelam HCl could reduce hepatic insulin resistance and lead to a decrease in hepatic glucose production (HGP). The observation by Schwartz et al (4) of significantly reduced fasting plasma glucose concentrations in colesevelam-treated T2DM patients suggests such a reduction in HGP, as fasting hyperglycemia is a direct function of HGP. Colesevelam HCl could also decrease post-prandial glucose absorption. Changes in glucose absorption with other bile acid sequestrants (BAS) (5) and bile acids (6) have been reported.
With regard to molecular mediators of the colesevelam effect on glucose metabolism, there is considerable evidence emerging about the role of bile acids and nuclear transcription factors, such as the farnesyl X receptor (FXR), in the regulation of glucose and lipid metabolism (7) (8) (9-15). Changes in cellular lipids or nuclear hormone receptors might directly alter HGP although mechanisms leading to changes in hepatic lipid and glucose metabolism by colesevelam HCl have not previously been investigated.
Significant changes in cholesterol and bile acid synthesis rates are expected with colesevelam treatment. BAS treatment can alter the transhepatic flux and compositional profile of the circulating bile acid pool (16), and thus its hydrophobicity, and this may effect the activation of nuclear receptors, including FXR (17; 18). Determination of the effect of colesevelam treatment on bile acid synthesis may provide evidence for its metabolic effects. The effects on hepatic fatty acid synthesis (de novo lipogenesis or DNL) have not been investigated and may provide further evidence for a metabolic effect of colesevelam.
Specific hypotheses about its mode of action will be tested, focusing on hepatic glucose metabolism and intestinal glucose absorption.
- Conditions
- Diabetes
- Being tested
- Colesevelam HCL, Placebo
- Keywords
- type two diabetes, gluconeogenesis, glucose, lipid synthesis, hepatic insulin sensitivity, colesevelam HCl
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colesevelam HCLDrug
Also called WelChol
Colesevelam HCL 625 mg: 3 tablets twice per day
PlaceboDrug
Placebo tablets: 3 tablets twice per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo tablet 3 tablets 2x/day | Placebo comparator | Type-2 diabetes mellitus patients Receives: Drug: Placebo |
| Colesevelam HCL 625 mg: 3 tablets 2x/day | Experimental | Type-2 diabetes mellitus patients Receives: Drug: Colesevelam HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Endogenous Glucose Production (EGP)
Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment.
Measured: baseline and 12 weeks
Fasting Gluconeogenesis
Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment.
Measured: baseline and 12 weeks
Fasting Glycogenolysis
Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment.
Measured: baseline and 12 weeks
Rate of Appearance of Exogenous Glucose (Glucose Absorption)
Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported.
Measured: baseline and 12 weeks
Secondary outcomes (6)
Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)
Changes from baseline of total GLP-1 AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes
Measured: baseline and 12 weeks
Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC
Changes from baseline of total GIP-1 AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes
Measured: baseline and 12 weeks
Fasting Fractional De Novo Lipogenesis (DNL)
Changes from baseline in fasting fractional DNL after 12 weeks of colesevelam or placebo treatment were calculated. Fractional DNL represents the fraction of palmitate in very-low density lipoproteins-triglycerides (VLDL-TG) that was newly synthesized.
Measured: baseline and 12 weeks
Fasting Fractional Cholesterol Synthesis
Changes from baseline in fasting fractional cholesterol synthesis after 12 weeks of colesevelam or placebo treatment. Fractional Cholesterol synthesis represents the fraction of free cholesterol in plasma that was newly synthesised.
Measured: baseline and 12 weeks
Postprandial Fractional Cholic Acid Synthesis
Changes from baseline in fractional cholic acid synthesis after 12 weeks of colesevelam or placebo treatment were evaluated. Fractional cholic acid synthesis represents the relative amount of cholic acid that is made from newly synthesised cholesterol.
Measured: baseline and 12 weeks
Glucagon AUC
Changes from baseline of glucagon AUC after 12 weeks of placebo or colesevelam treatment.
AUC values were calculated by the trapezoid method using all results between 0 and 300 minutes
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carine Beysen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Carine Beysen, KineMed
- Investigators
- Carine Beysen, PhD, Principal investigator, KineMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596427
- Sponsor's protocol ID
- KM-11A
- Status last verified
- Oct 2012
- First submitted
- 8 Jan 2008
- Last updated
- 12 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grundy SM, Ahrens EH Jr, Salen G. Interruption of the enterohepatic circulation of bile acids in man: comparative effects of cholestyramine and ileal exclusion on cholesterol metabolism. J Lab Clin Med. 1971 Jul;78(1):94-121. No abstract available.
PubMed 5569253Shepherd J, Packard CJ, Bicker S, Lawrie TD, Morgan HG. Cholestyramine promotes receptor-mediated low-density-lipoprotein catabolism. N Engl J Med. 1980 May 29;302(22):1219-22. doi: 10.1056/NEJM198005293022202.
PubMed 7366673Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.
PubMed 17379048Jenkins DJ, Wolever TM, Leeds AR, Gassull MA, Haisman P, Dilawari J, Goff DV, Metz GL, Alberti KG. Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. Br Med J. 1978 May 27;1(6124):1392-4. doi: 10.1136/bmj.1.6124.1392.
PubMed 647304Beysen C, Murphy EJ, Deines K, Chan M, Tsang E, Glass A, Turner SM, Protasio J, Riiff T, Hellerstein MK. Effect of bile acid sequestrants on glucose metabolism, hepatic de novo lipogenesis, and cholesterol and bile acid kinetics in type 2 diabetes: a randomised controlled study. Diabetologia. 2012 Feb;55(2):432-42. doi: 10.1007/s00125-011-2382-3. Epub 2011 Dec 2.
PubMed 22134839
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Colesevelam HCl on Hepatic Insulin Sensitivity, Gluconeogenesis, Glucose Absorption and Lipid Synthesis in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00596427
- Acronym / sponsor ID
- KM-11A
- Conditions
- Diabetes
- Keywords
- type two diabetes, gluconeogenesis, glucose, lipid synthesis, hepatic insulin sensitivity, colesevelam HCl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Carine BeysenIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mechanism by which colesevelam HCl lowers glucose is not known. Knowledge of the potential mechanism of action is important for defining the role of the drug among oral antidiabetic agents available for use in subjects with diabetes. The objective of this study is to provide insight into the mechanisms of action of colesevelam HCl in T2DM. The mechanisms of interest include hepatic insulin sensitivity, rate of appearance of exogenous glucose and changes in incretin hormone concentrations.
Detailed description
Colesevelam HCl (marketed in the U.S. as WelChol®) is a non-absorbed polymer that binds bile acids in the intestine, impeding their reabsorption, and is indicated to lower low-density lipoprotein cholesterol (LDL-C) in subjects with hypercholesterolemia. As the bile acid pool becomes depleted, the hepatic enzyme cholesterol 7-(alpha)-hydroxylase is upregulated, increasing the conversion of cholesterol to bile acids. This causes an increased demand for cholesterol in the liver, resulting in the dual effect of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase, and increasing the number of hepatic low-density lipoprotein (LDL) receptors. These compensatory effects increase the clearance of LDL-C from the blood, decreasing serum LDL C levels (1; 2).
Recently, it has been shown that colesevelam HCl also improves glycemic control in subjects with T2DM who are not controlled adequately on metformin, sulfonylurea or a combination of the two drugs (3). The mechanism of action for glucose lowering is not known. Improved glycemic control with colesevelam HCl treatment could be due to any of several mechanisms. Colesevelam HCl could reduce hepatic insulin resistance and lead to a decrease in hepatic glucose production (HGP). The observation by Schwartz et al (4) of significantly reduced fasting plasma glucose concentrations in colesevelam-treated T2DM patients suggests such a reduction in HGP, as fasting hyperglycemia is a direct function of HGP. Colesevelam HCl could also decrease post-prandial glucose absorption. Changes in glucose absorption with other bile acid sequestrants (BAS) (5) and bile acids (6) have been reported.
With regard to molecular mediators of the colesevelam effect on glucose metabolism, there is considerable evidence emerging about the role of bile acids and nuclear transcription factors, such as the farnesyl X receptor (FXR), in the regulation of glucose and lipid metabolism (7) (8) (9-15). Changes in cellular lipids or nuclear hormone receptors might directly alter HGP although mechanisms leading to changes in hepatic lipid and glucose metabolism by colesevelam HCl have not previously been investigated.
Significant changes in cholesterol and bile acid synthesis rates are expected with colesevelam treatment. BAS treatment can alter the transhepatic flux and compositional profile of the circulating bile acid pool (16), and thus its hydrophobicity, and this may effect the activation of nuclear receptors, including FXR (17; 18). Determination of the effect of colesevelam treatment on bile acid synthesis may provide evidence for its metabolic effects. The effects on hepatic fatty acid synthesis (de novo lipogenesis or DNL) have not been investigated and may provide further evidence for a metabolic effect of colesevelam.
Specific hypotheses about its mode of action will be tested, focusing on hepatic glucose metabolism and intestinal glucose absorption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo tablet 3 tablets 2x/day | Placebo comparator | Drug: PlaceboType-2 diabetes mellitus patients |
| Colesevelam HCL 625 mg: 3 tablets 2x/day | Experimental | Drug: Colesevelam HCLType-2 diabetes mellitus patients |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the trial:
- Have given written informed consent
- Male or Female
- oral, injectable, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide or female condom plus spermicide
- Previously diagnosed or newly diagnosed with T2DM
Key exclusion criteria (22 listed)
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Treatment with lipid lowering medication other than statins
- Treatment with statins that have not been stable for 3 months before screening
- Treatment with colesevelam HCl, cholestyramine or colestipol for hyperlipidemia within the last 3 months of screening
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 |
|---|---|---|
| Colesevelam HCLAlso: WelCholColesevelam HCL 625 mg: 3 tablets twice per day | Drug | Colesevelam HCL 625 mg: 3 tablets 2x/day |
| PlaceboPlacebo tablets: 3 tablets twice per day | Drug | Placebo tablet 3 tablets 2x/day |
Primary outcome
Fasting Endogenous Glucose Production (EGP)
Time frame: baseline and 12 weeks
Changes from baseline of fasting EGP after 12 weeks of placebo or colesevelam treatment.
Fasting Gluconeogenesis
Time frame: baseline and 12 weeks
Change from baseline of fasting gluconeogenesis after 12 weeks of placebo or colesevelam treatment.
Fasting Glycogenolysis
Time frame: baseline and 12 weeks
Change from baseline of fasting glycogenolysis after 12 weeks of placebo or colesevelam treatment.
Rate of Appearance of Exogenous Glucose (Glucose Absorption)
Time frame: baseline and 12 weeks
Change from baseline of the rate of appearance of oral glucose after 12 weeks of placebo or colesevelam treatment. Mean of values obtained between 0 and 300 min is reported.
6 secondary outcomes
Total Glucagon-like Peptide (GLP-1) Area Under the Curve (AUC)
Time frame: baseline and 12 weeks
Total Glucose-dependent Insulinotropic Polypeptide (GIP) AUC
Time frame: baseline and 12 weeks
Fasting Fractional De Novo Lipogenesis (DNL)
Time frame: baseline and 12 weeks
Fasting Fractional Cholesterol Synthesis
Time frame: baseline and 12 weeks
Postprandial Fractional Cholic Acid Synthesis
Time frame: baseline and 12 weeks
Glucagon AUC
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 5569253Grundy SM, Ahrens EH Jr, Salen G. Interruption of the enterohepatic circulation of bile acids in man: comparative effects of cholestyramine and ileal exclusion on cholesterol metabolism. J Lab Clin Med. 1971 Jul;78(1):94-121. No abstract available.
- Background: PubMed 7366673Shepherd J, Packard CJ, Bicker S, Lawrie TD, Morgan HG. Cholestyramine promotes receptor-mediated low-density-lipoprotein catabolism. N Engl J Med. 1980 May 29;302(22):1219-22. doi: 10.1056/NEJM198005293022202.
- Background: PubMed 17379048Zieve FJ, Kalin MF, Schwartz SL, Jones MR, Bailey WL. Results of the glucose-lowering effect of WelChol study (GLOWS): a randomized, double-blind, placebo-controlled pilot study evaluating the effect of colesevelam hydrochloride on glycemic control in subjects with type 2 diabetes. Clin Ther. 2007 Jan;29(1):74-83. doi: 10.1016/j.clinthera.2007.01.003.
- Background: PubMed 647304Jenkins DJ, Wolever TM, Leeds AR, Gassull MA, Haisman P, Dilawari J, Goff DV, Metz GL, Alberti KG. Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. Br Med J. 1978 May 27;1(6124):1392-4. doi: 10.1136/bmj.1.6124.1392.
- Derived from this study: PubMed 22134839Beysen C, Murphy EJ, Deines K, Chan M, Tsang E, Glass A, Turner SM, Protasio J, Riiff T, Hellerstein MK. Effect of bile acid sequestrants on glucose metabolism, hepatic de novo lipogenesis, and cholesterol and bile acid kinetics in type 2 diabetes: a randomised controlled study. Diabetologia. 2012 Feb;55(2):432-42. doi: 10.1007/s00125-011-2382-3. Epub 2011 Dec 2.
- KineMed, Inc.Link provided by the sponsor.
- Diablo Clinical Research, Inc.Link provided by the sponsor.
- WelCholLink provided by the sponsor.
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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.
Carine Beysen, PhD principal investigator
KineMed
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colesevelam HCL in people with Diabetes, run by Carine Beysen at 3 sites in United States.
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 16 inclusion and 22 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 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Endogenous Glucose Production (EGP) (time frame: baseline and 12 weeks). The study lists 4 primary outcomes in all. 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 NCT00596427, which also lists 5 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 12 Oct 2012.