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Diabetes MellitusTANDEMNCT02106039

Pulmonary Tuberculosis Patients With Diabetes Mellitus

A study testing intensive monitoring in people with Diabetes Mellitus and Pulmonary Tuberculosis, run by Universitas Padjadjaran at 3 sites in 3 countries.

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 evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Pulmonary Tuberculosis
What is being tested?
intensive monitoring
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
3 sitesin 3 countries
Study dates
28 Apr 2014to 21 Dec 2017
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult (> 18 years old) diabetes mellitus patients
  • diagnosed as having active pulmonary TB
  • willing to join the study

Who cannot join

  • under TB treatment more than 72 hours
  • steroid-induced or gestational diabetes

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Indonesia1 site

  • Faculty of Medicine, Universitas Padjadjaran

    Bandung, West Java, 40161

Other trials in Indonesia

Peru1 site

  • Universidad Peruana Cayetano Heredia

    Lima, San Martin de Porres, 31

Other trials in Peru

Romania1 site

  • University of Medicine and Pharmacy Craiova

    Bucharest

Other trials in Romania

About this study

Official title: Concurrent Tuberculosis and Diabetes: Clinical Monitoring, and Microbiological and Immunological Effects of Diabetes During Tuberculosis Treatment

The purpose of this study is to evaluate the effect of enhanced glycemic monitoring of diabetes upon diabetes glycaemic control during tuberculosis treatment in tuberculosis- diabetes patients.

Read the detailed description

Tight glycemic control may improve tuberculosis (TB) treatment outcome and help reduce symptoms. However, active TB and TB treatment hamper glycemic control. Patients starting TB treatment experience rapid changes in appetite, body composition, and inflammation (which increases insulin resistance); inflammation is a feature of untreated TB and following an increase as a result of initial bacterial killing, inflammation subsides with successful treatment. In addition, TB medication (rifampicin) increases the metabolism of oral anti-diabetic drugs including the widely used sulphonylureas and thiazolidinediones, though a possible interaction with the antidiabetic drug metformin has not been previously examined. Frequent monitoring of blood glucose with adjustments in anti-diabetes medication during the course of TB treatment may therefore be needed. However, frequent monitoring is associated with additional costs, and tools and skills for glucose monitoring and diabetes treatment may be lacking in TB or pulmonary clinics, creating a need to refer patients to other health providers. As such, a less intense schedule, preferably following the established decision points in TB treatment after 2 and 6 months would offer significant advantage. None of these issues have been addressed systematically so far.

Being tested
intensive monitoring
Keywords
diabetes mellitus, tuberculosis, management, randomized controlled trial
Medical subject headings
Diabetes Mellitus, Tuberculosis, Pulmonary, Tuberculosis

What participants receive

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

  • intensive monitoringProcedure or surgery

Study groups in NCT02106039
Study groupRoleWhat they receive
intensive monitoringExperimentalmore intensive monitoring strategy of blood glucose and clinical review
Receives: Procedure: intensive monitoring
standard monitoringNo interventionglucose monitoring followed the prevailing practice at each site

What is being measured

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

  1. Better diabetes control in diabetes patients with tuberculosis under treatment

    Diabetes control is determined by HbA1c level (unit: %) which will be measured at month 3 and 6 of TB treatment.

    Measured: Up to 6 months during TB treatment

Secondary outcomes (3)

  1. Cost-effectiveness of different strategies for diabetes management during TB treatment

    Cost analysis will include all cost for lab analysis, transportation for follow up visit, expenses for medications, all complications caused by uncontrolled diabetes (including hospitalization, medications for co morbidities)

    Measured: Up to 6 months

  2. Measurement of long-term requirements for diabetes management in TB patients diagnosed with diabetes after TB treatment completed

    Clinical characteristics (i.e. blood pressure, glucose control, kidney function, quality of life (QoL) of diabetes mellitus patients with TB after completing TB treatment will be measured and will be compared between both groups.

    Measured: 12 months after completing TB treatment

  3. Association between glycemic control and clinical-microbiological response to TB treatment

    Association between glycemic control and clinical response to TB treatment will be determined by measuring: increasing of body weight, symptoms relieve, treatment outcome (cured, completed, failure and default), and will be compared between groups.

    Association between glycemic control and microbiological response to TB treatment will be determined by measuring sputum conversion time (time to negative culture), and will be compared between groups.

    Measured: up to 6 months

Timeline

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

  1. First posted7 Apr 2014 (estimated)
  2. Study start28 Apr 2014
  3. Primary completion21 Feb 2017
  4. Study completion21 Dec 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02106039
Sponsor's protocol ID
TB-201403.01
Acronym
TANDEM
Status last verified
Sep 2017
First submitted
19 Mar 2014
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Baker MA, Harries AD, Jeon CY, Hart JE, Kapur A, Lonnroth K, Ottmani SE, Goonesekera SD, Murray MB. The impact of diabetes on tuberculosis treatment outcomes: a systematic review. BMC Med. 2011 Jul 1;9:81. doi: 10.1186/1741-7015-9-81.

    PubMed 21722362

  • Ruslami R, Aarnoutse RE, Alisjahbana B, van der Ven AJ, van Crevel R. Implications of the global increase of diabetes for tuberculosis control and patient care. Trop Med Int Health. 2010 Nov;15(11):1289-99. doi: 10.1111/j.1365-3156.2010.02625.x.

    PubMed 20955495

  • Bidstrup TB, Stilling N, Damkier P, Scharling B, Thomsen MS, Brosen K. Rifampicin seems to act as both an inducer and an inhibitor of the metabolism of repaglinide. Eur J Clin Pharmacol. 2004 Apr;60(2):109-14. doi: 10.1007/s00228-004-0746-z. Epub 2004 Mar 19.

    PubMed 15034704

  • Hatorp V, Hansen KT, Thomsen MS. Influence of drugs interacting with CYP3A4 on the pharmacokinetics, pharmacodynamics, and safety of the prandial glucose regulator repaglinide. J Clin Pharmacol. 2003 Jun;43(6):649-60.

    PubMed 12817528

  • Jaakkola T, Backman JT, Neuvonen M, Laitila J, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics of pioglitazone. Br J Clin Pharmacol. 2006 Jan;61(1):70-8. doi: 10.1111/j.1365-2125.2005.02515.x.

    PubMed 16390353

  • Niemi M, Backman JT, Neuvonen M, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of nateglinide in healthy subjects. Br J Clin Pharmacol. 2003 Oct;56(4):427-32. doi: 10.1046/j.1365-2125.2003.01884.x.

    PubMed 12968988

  • Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivisto KT. Rifampin decreases the plasma concentrations and effects of repaglinide. Clin Pharmacol Ther. 2000 Nov;68(5):495-500. doi: 10.1067/mcp.2000.111183.

    PubMed 11103752

  • Niemi M, Backman JT, Neuvonen M, Neuvonen PJ, Kivisto KT. Effects of rifampin on the pharmacokinetics and pharmacodynamics of glyburide and glipizide. Clin Pharmacol Ther. 2001 Jun;69(6):400-6. doi: 10.1067/mcp.2001.115822.

    PubMed 11406737

  • Niemi M, Kivisto KT, Backman JT, Neuvonen PJ. Effect of rifampicin on the pharmacokinetics and pharmacodynamics of glimepiride. Br J Clin Pharmacol. 2000 Dec;50(6):591-5. doi: 10.1046/j.1365-2125.2000.00295.x.

    PubMed 11136298

  • Park JY, Kim KA, Kang MH, Kim SL, Shin JG. Effect of rifampin on the pharmacokinetics of rosiglitazone in healthy subjects. Clin Pharmacol Ther. 2004 Mar;75(3):157-62. doi: 10.1016/j.clpt.2003.10.003.

    PubMed 15001966

  • Park JY, Kim KA, Park PW, Park CW, Shin JG. Effect of rifampin on the pharmacokinetics and pharmacodynamics of gliclazide. Clin Pharmacol Ther. 2003 Oct;74(4):334-40. doi: 10.1016/S0009-9236(03)00221-2.

    PubMed 14534520

  • Syvalahti E, Pihlajamaki K, Iisalo E. Effect of tuberculostatic agents on the response of serum growth hormone and immunoreactive insulin to intravenous tolbutamide, and on the half-life of tolbutamide. Int J Clin Pharmacol Biopharm. 1976 Mar;13(2):83-9.

    PubMed 1254383

  • Zilly W, Breimer DD, Richter E. Induction of drug metabolism in man after rifampicin treatment measured by increased hexobarbital and tolbutamide clearance. Eur J Clin Pharmacol. 1975 Dec 19;9(2-3):219-27. doi: 10.1007/BF00614021.

    PubMed 1233266

Questions about this trial

What is this clinical trial studying?

A study testing intensive monitoring in people with Diabetes Mellitus and Pulmonary Tuberculosis, run by Universitas Padjadjaran at 3 sites in 3 countries.

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 3 inclusion and 2 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 Apr 2019. 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 Indonesia, Peru, Romania. 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.

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?

Better diabetes control in diabetes patients with tuberculosis under treatment (time frame: Up to 6 months during TB treatment). 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 NCT02106039, 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 Apr 2019.

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