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Diabetes MellitusPhase 4NCT02754739

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

A Phase 4 study testing Pravastatin and Nutritional education only in people with Diabetes Mellitus and Prediabetic State, run by Samsung Medical Center at 1 site in South Korea.

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

An increased risk of incident diabetes with statin therapy have been reported in several studies. However, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (Scatter… Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Diabetes Mellitus, Prediabetic State
What is being tested?
Pravastatin and Nutritional education only
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteSouth Korea
Study dates
15 Apr 2014to 31 Aug 2017
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 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects have early diabetes mellitus or prediabetes. Early diabetes mellitus or prediabetes are defined according to the following criteria; Subjects have two or more of the following three, or they have one of them at the initial test and the repeat test.
  • hemoglobin A1C 5.7-9.0%
  • fasting plasma glucose level 100mg/dL or more
  • plasma glucose level 140mg/dL or more at 2 hours after 75g oral glucose tolerance test
  • Subjects have one of the following three;
  • Low-density lipoprotein cholesterol (LDL-cholesterol) 130mg/dL or more, and body mass index (BMI) > 23 kg/m2,
  • 10 year atherosclerotic cardiovascular disease (ASCVD) risk of 7.5% or more, which is assessed by the ASCVD-Risk-Estimator (Circulation.2014;129:S1-S45)
  • In diabetic patients, LDL-cholesterol 100mg/dL or more

Who cannot join

  • Hemoglobin A1C > 9.0%
  • History of statin use in three months
  • Use of oral antidiabetic drugs except for metformin in three months
  • History of malignant diseases (cancers)
  • History of coronary artery diseases, heart failure, arrhythmia, valvular heart diseases, or cerebrovascular diseases
  • Pregnant
Show all 10Show fewer
  • serum creatinine level > 1.5 mg/dL
  • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels higher than 80 U/l
  • Taking weight loss medications, corticosteroids, Angiotensin converting enzyme (ACE) inhibitors, or estrogen replacement therapy
  • Chronic hepatitis B or chronic hepatitis C

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710

Other trials in South Korea

About this study

An increased risk of incident diabetes with statin therapy have been reported in several studies. However, it is not recommended to limit the use of statin for this reason since the absolute risk increase was small, and the cardiovascular event rate reduction with statins overweighed the risk of new diabetes (Scatter N et al. Lancet, 2010). Moreover, each statin may have different effect on the development of incident diabetes. In the West of Scotland Coronary Prevention Study, pravastatin therapy reduced the hazard of becoming diabetic by 30%. Also, with pravastatin use, an increase in adiponectin level, which is related to the improvement in insulin sensitivity, has been reported. In this clinical trial, the investigators are aiming to evaluate the effect of pravastatin on insulin resistance, insulin secretion, glycemic control, and adiponectin level in participants with prediabetes or early diabetes by assigning them in a 24 weeks of pravastatin therapy group or in a placebo group.

Being tested
Pravastatin, Placebo (for Pravastatin), Nutritional education only
Keywords
Pravastatin, Insulin Resistance
Medical subject headings
Diabetes Mellitus, Prediabetic State, Insulin Resistance

What participants receive

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

  • PravastatinDrug

    Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist

  • Placebo (for Pravastatin)Drug

    Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist

  • Nutritional education onlyBehavioural

    Also called Open-label control

    Only nutritional education by a nutritionist

Study groups in NCT02754739
Study groupRoleWhat they receive
PravastatinExperimentalPravastatin 40mg tablet by mouth, once daily for 24 weeks. Also, nutritional education was provided to participants in all arms by a nutritionist, and participants were instructed to follow the educated guideline.
Receives: Drug: Pravastatin
PlaceboPlacebo comparatorPlacebo drug indistiguishable from pravastatin 40mg tablet, by mouth, once daily for 24 weeks. Also, nutritional education was provided to participants in all arms by a nutritionist, and participants were instructed to follow the educated guideline.
Receives: Drug: Placebo (for Pravastatin)
Open-label controlOtherNo medication. Only nutritional education was provided to participants by a nutritionist, and participants were instructed to follow the educated guideline.
Receives: Behavioral: Nutritional education only

What is being measured

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

  1. Insulin resistance assessed by HOMA-IR (homeostatic model assessment index for insulin resistance)

    compared to the HOMA-IR level calculated at the initial visit (at the beginning of the 24 weeks of medication period)

    Measured: at the end of the 24 weeks of medication period

Secondary outcomes (9)

  1. Insulin resistance assessed by Matsuda index calculated through 75g oral glucose tolerance test

    calculated according to a method described in a previous study (Matsuda M et al. Diabetes Care, 1999), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period). It takes 120 minutes to perform 75g oral glucose tolerance test

    Measured: at the end of the 24 weeks of medication period

  2. Insulin secretion capacity assessed by insulinogenic index (INS index) during 75g oral glucose tolerance test

    the ratio relating enhancement of circulating insulin in 30min [in pmol/L] to magnitude of corresponding glycemic stimulus in 30min [in mmol/L] during the oral glucose tolerance test (H.S. Seltze et al. J. Clin. Investig., 1967), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period)

    Measured: at the end of the 24 weeks of medication period

  3. Insulin resistance assessed by the quantitative insulin sensitivity check index (QUICKI)

    calculated using fasting insulin in uIU/mL and fasting plasma glucose in mg/dL according to the method described in a previous study (A. Katz et al. J. Clin. Endocrinol. Metab., 2000), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period)

    Measured: at the end of the 24 weeks of medication period

  4. Insulin secretory capacity relative to insulin resistance assessed by the oral disposition index

    calculated according to a method described in a previous study (K.M. Utzschneider et al.Diabetes Care, 2008), compared to the results at the initial visit (at the beginning of the 24 weeks of medication period)

    Measured: at the end of the 24 weeks of medication period

  5. Glycemic control evaluated by fasting glucose level (mg/dL)

    compared to the values at the initial visit

    Measured: at the end of the 24 weeks of medication period

  6. Glycemic control evaluated by hemoglobin A1C (%)

    compared to the values at the initial visit

    Measured: at the end of the 24 weeks of medication period

  7. Plasma adioponectin level (μg/ml), an adipocyte-derived insulin-sensitizing hormone level

    compared to the values at the initial visit

    Measured: at the end of the 24 weeks of medication period

  8. Biomarkers predicting cardiovascular diseases, assessed by high sensitive C-reactive protein (hsCRP) (mg/dL)

    compared to the values at the initial visit

    Measured: at the end of the 24 weeks of medication period

  9. Biomarkers predicting cardiovascular diseases, assessed by plasminogen activator inhibitor-1 (PAI-1) (ng/mL)

    compared to the values at the initial visit

    Measured: at the end of the 24 weeks of medication period

Timeline

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

  1. First posted28 Apr 2016 (estimated)
  2. Study start15 Apr 2014
  3. Primary completion31 Aug 2017
  4. Study completion31 Aug 2017

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
Crossover
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02754739
Sponsor's protocol ID
2012-12-103
Status last verified
Sep 2018
First submitted
9 Apr 2016
Last updated
13 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.

    PubMed 20167359

  • Rajpathak SN, Kumbhani DJ, Crandall J, Barzilai N, Alderman M, Ridker PM. Statin therapy and risk of developing type 2 diabetes: a meta-analysis. Diabetes Care. 2009 Oct;32(10):1924-9. doi: 10.2337/dc09-0738.

    PubMed 19794004

  • Freeman DJ, Norrie J, Sattar N, Neely RD, Cobbe SM, Ford I, Isles C, Lorimer AR, Macfarlane PW, McKillop JH, Packard CJ, Shepherd J, Gaw A. Pravastatin and the development of diabetes mellitus: evidence for a protective treatment effect in the West of Scotland Coronary Prevention Study. Circulation. 2001 Jan 23;103(3):357-62. doi: 10.1161/01.cir.103.3.357.

    PubMed 11157685

  • Guclu F, Ozmen B, Hekimsoy Z, Kirmaz C. Effects of a statin group drug, pravastatin, on the insulin resistance in patients with metabolic syndrome. Biomed Pharmacother. 2004 Dec;58(10):614-8. doi: 10.1016/j.biopha.2004.09.005.

    PubMed 15589072

  • Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.

    PubMed 10480510

  • Seltzer HS, Allen EW, Herron AL Jr, Brennan MT. Insulin secretion in response to glycemic stimulus: relation of delayed initial release to carbohydrate intolerance in mild diabetes mellitus. J Clin Invest. 1967 Mar;46(3):323-35. doi: 10.1172/JCI105534.

    PubMed 6023769

  • Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ. Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans. J Clin Endocrinol Metab. 2000 Jul;85(7):2402-10. doi: 10.1210/jcem.85.7.6661.

    PubMed 10902785

  • Utzschneider KM, Prigeon RL, Faulenbach MV, Tong J, Carr DB, Boyko EJ, Leonetti DL, McNeely MJ, Fujimoto WY, Kahn SE. Oral disposition index predicts the development of future diabetes above and beyond fasting and 2-h glucose levels. Diabetes Care. 2009 Feb;32(2):335-41. doi: 10.2337/dc08-1478. Epub 2008 Oct 28.

    PubMed 18957530

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pravastatin and Nutritional education only in people with Diabetes Mellitus and Prediabetic State, run by Samsung Medical Center at 1 site in South Korea.

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 8 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 13 Sep 2018. 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 South Korea. 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.

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?

Insulin resistance assessed by HOMA-IR (homeostatic model assessment index for insulin resistance) (time frame: at the end of the 24 weeks of medication period). 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 NCT02754739, which also lists 8 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 13 Sep 2018.

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