Diabetes Research on Patient Stratification

Type2 Diabetes Clinical Trial

— DIRECT  

Official title:

DIabetes REsearCh on Patient straTification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814915
• Other study ID #: IMIDIRECT_2012
• Status: Completed
• Start date: October 15, 2012
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overarching goal of the IMI DIRECT (Innovative Medicines Initiative Diabetes Research on Patient Stratification) Consortium is the identification of biomarkers that aid therapeutic targeting in prediabetes (Study 1) or early onset type 2 diabetes (Study 2).

Description:

There are two multicentre prospective cohort studies within the glycaemic deterioration work package of IMI DIRECT (WP2). These two cohorts are designed to address the area of glycaemic deterioration by amassing data and biomaterials that will be used to discover novel biomarkers for glycaemic deterioration in people at high risk of developing type 2 diabetes (Study 1) and in those who have recently been diagnosed with the disease (Study 2).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3049
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

Study 1

Inclusion criteria

• No treatment with insulin-sensitising, glucose-lowering or other antidiabetic drugs

• Fasting capillary blood glucose <10 mmol/l at baseline

• White European (self-report of parental ethnicity)

• Age =35 and <75 years

Exclusion criteria

• Diagnosed diabetes of any type, HbA1c =6.5% (48 mmol/mol) or fasting plasma glucose =7.0 mmol/l or 2 h plasma glucose >11.0 mmol/l previously

• For women, pregnancy, lactation or plans to conceive within the study period

• Use of a pacemaker

• Any other significant medical reason for exclusion as determined by the investigator

Study 2

Inclusion Criteria:

• Patients diagnosed with type 2 diabetes not less than 6 months and not more than 24 months before baseline examination

• Management by lifestyle with or without metformin therapy

• All HbA1c <7.6% (<60 mmol/mol) within previous 3 months

• White European

• Age =35 and <75

• Estimated GFR >50 ml/min'

Exclusion Criteria:

• Type 1 diabetes

• A previous HbA1c >9.0% (>75 mmol/mol)

• Prior treatment with insulin or an oral hypoglycaemic agent other than metformin

• BMI <20 or >50 kg/m2

• Pregnancy, lactation or plans to conceive within the study period

• Any other significant medical reason for exclusion as determined by the investigator

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

References & Publications (1)

Koivula RW, Heggie A, Barnett A, Cederberg H, Hansen TH, Koopman AD, Ridderstråle M, Rutters F, Vestergaard H, Gupta R, Herrgård S, Heymans MW, Perry MH, Rauh S, Siloaho M, Teare HJ, Thorand B, Bell J, Brunak S, Frost G, Jablonka B, Mari A, McDonald TJ, Dekker JM, Hansen T, Hattersley A, Laakso M, Pedersen O, Koivisto V, Ruetten H, Walker M, Pearson E, Franks PW; DIRECT Consortium. Discovery of biomarkers for glycaemic deterioration before and after the onset of type 2 diabetes: rationale and design of the epidemiological studies within the IMI DIRECT Consortium. Diabetologia. 2014 Jun;57(6):1132-42. doi: 10.1007/s00125-014-3216-x. Epub 2014 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic deterioration	Change in glucose (or HbA1c) over time and/or progression to anti diabetic medications/insulin	Up to 10 years follow-up