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Table 4 Reported eligibility criteria and key baseline characteristics of type 2 diabetes randomised controlled trials (n = 23)

From: Clinical drug trials in general practice: how well are external validity issues reported?

 

Exclusion criteria in total of 23 trials

Baseline data of included patients. Mean (CI)

Data from other population/GP studies for comparison

Exclusion criteria

Scotlanda

Belgiumb

Norwayc

Age

 

58.2 years (56.3–60.1)

66.3

58

62.4

  < 18

19

    

  < 21

1

    

  < 40

1

    

  < 65

1

    

 No lower limit reported

1

    

  > 70–79

10

    

  > 80

5

    

 No upper limit reported

8

    

Gender

 

54.2% male (52.4–56.0)

54.3

51.9

49.9

 Females

0

    

 Pregnancy

3

    

 Lack of contraception use

3

    

 Breastfeeding

1

    

HbA1c

 

8.1% (7.85–8.35)

7.4

7.1

7.7

  < 6

1

    

  < 6.5

4

    

  < 7

8

    

  < 7.5

5

    

 No lower limit reported

5

    

  > 9

2

    

  > 10–10.9

11

    

  > 11

4

    

  > 12

2

    

 No upper limit reported

4

    

BMI

 

30.6 kg/m2 (30.1–31.1)

31.4

31

29.7

  < 18

1

    

  < 22–23

4

    

  > 35

3

    

  > 40–45

6

    

 No BMI exclusion criteria reported

14

    

Medical comorbidities

 

7 trials reported participants’ comorbidity

   

 Coronary heart disease

14

   

 Heart failure

9

    

 Stroke

4

    

 Renal dysfunction

17

    

 Liver dysfunction

14

    

 Other type of diabetes

13

    

 Previous or suspected drug intolerance

3

    

 Other disease

7

    

Medication related

 

5 trials reported participants’ co-medication

   

 Concurrent medication

8

    

Race/ethnicity

0

19 trials reported participants’ race/ethnicity

   
  1. Randomised controlled trials for type 2 diabetes drugs: DPP4-inhibitors (n = 12), insulins (n = 5), PPAR-agonists (n = 2), thiazolidinedones (n = 2) and others (n = 2). The numbers of trials reporting different key eligibility criteria are presented with mean baseline characteristics of included patients. Baseline characteristics are compared to published data from three population based or general practice studies
  2. Data from other studies:
  3. aScotland: Nationwide diabetes clinical database [9]
  4. bBelgium: General practice morbidity registration [26]
  5. cNorway: Population based study HUNT-2 [25]