Randomized comparison of pramlintide or mealtime insulin added to basal insulin treatment for patients with type 2 diabetes.

Riddle M, Pencek R, Charenkavanich S, Lutz K, Wilhelm K, Porter L

Diabetes care5 Jun 2009Cited by 41 (Europe PMC)

PMID19502544PMCIDPMC2732154DOI10.2337/dc09-0395PepBankPUB-19502544

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, more pramlintide patients achieved A1C <=7.0% without weight gain or severe hypoglycemia than rapid-acting insulin patients.
In plain wordsIn type 2 diabetes, more pramlintide patients reached A1C <=7.0% without weight gain or severe hypoglycemia than rapid-acting insulin patients.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseA1C target without weight gain or severe hypoglycemia
Study
n = 113
Comparator
Rapid-acting insulin analog
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Measurements
Composite target achievement
30%
pramlintide
Composite target achievement
11%
rapid-acting insulin
Source sentences
Summary
More pramlintide- than RAIA-treated patients achieved the primary end point (30 vs. 11%, P = 0.018) with a similar dose of basal insulin.
2 context sentences(design, population, supporting numbers)
Summary · context
The proportion of patients achieving A1C < or =7.0% without weight gain or severe hypoglycemia at week 24 was the primary end point.
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254401
02HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, basal insulin doses were similar with pramlintide and rapid-acting insulin.
In plain wordsIn patients with type 2 diabetes, basal insulin doses were similar with pramlintide and rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeBasal insulin dose
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Glycemic control · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Source sentences
Summary
More pramlintide- than RAIA-treated patients achieved the primary end point (30 vs. 11%, P = 0.018) with a similar dose of basal insulin.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254402
03HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, fasting glucose levels and reductions were similar with pramlintide and rapid-acting insulin.
In plain wordsIn patients with type 2 diabetes, fasting glucose and its reduction were similar with pramlintide and rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeFasting plasma glucose
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Glycemic control · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Measurements
FPG
122 mg/dl
pramlintide at 24 weeks
FPG
123 mg/dl
rapid-acting insulin at 24 weeks
FPG change
−31 mg/dl
pramlintide
FPG change
−34 mg/dl
rapid-acting insulin
Source sentences
Summary
Pramlintide and an RAIA yielded similar mean +/- SEM values for FPG and A1C at 24 weeks (122 +/- 7 vs. 123 +/- 5 mg/dl and 7.2 +/- 0.2 vs. 7.0 +/- 0.1%, respectively) and similar least squares mean reductions from baseline to end point (-31 +/- 6 vs. -34 +/- 6 mg/dl and -1.1 +/- 0.2 vs. -1.3 +/- 0.2%, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254403
04HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, A1C levels and reductions were similar with pramlintide and rapid-acting insulin.
In plain wordsIn patients with type 2 diabetes, A1C and its reduction were similar with pramlintide and rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeA1C
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Glycemic control · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Measurements
A1C
7.2%
pramlintide at 24 weeks
A1C
7%
rapid-acting insulin at 24 weeks
A1C change
−1.1%
pramlintide
A1C change
−1.3%
rapid-acting insulin
Source sentences
Summary
Pramlintide and an RAIA yielded similar mean +/- SEM values for FPG and A1C at 24 weeks (122 +/- 7 vs. 123 +/- 5 mg/dl and 7.2 +/- 0.2 vs. 7.0 +/- 0.1%, respectively) and similar least squares mean reductions from baseline to end point (-31 +/- 6 vs. -34 +/- 6 mg/dl and -1.1 +/- 0.2 vs. -1.3 +/- 0.2%, respectively).
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254404
05HumanRandomized controlled trialEfficacy outcome
In patients with type 2 diabetes, weight change was +0.0 kg with pramlintide versus +4.7 kg with rapid-acting insulin analogs.
In plain wordsIn patients with type 2 diabetes, weight stayed stable with pramlintide but increased with rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseWeight gain
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Body weight · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Measurements
Weight change
0 kg
pramlintide
Weight change
4.7 kg
rapid-acting insulin
Source sentences
Summary
RAIAs but not pramlintide caused weight gain (+4.7 +/- 0.7 vs. +0.0 +/- 0.7 kg, P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254405
06HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, mild to moderate hypoglycemia was less frequent with pramlintide than rapid-acting insulin.
In plain wordsIn patients with type 2 diabetes, mild to moderate low blood sugar was less frequent with pramlintide than rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseMild to moderate hypoglycemia
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Adverse events · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Measurements
Hypoglycemia
55%
pramlintide
Hypoglycemia
82%
rapid-acting insulin
Source sentences
Summary
Fewer patients reported mild to moderate hypoglycemia with pramlintide than with the RAIA (55 vs. 82%), but more patients reported nausea (21 vs. 0%).
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254406
07HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, nausea was more frequent with pramlintide than rapid-acting insulin.
In plain wordsIn patients with type 2 diabetes, nausea was more frequent with pramlintide than rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseNausea
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
120 microg · 24 weeksAs given in this study (human).
Measurements
Nausea
21%
pramlintide
Nausea
0%
rapid-acting insulin
Source sentences
Summary
Fewer patients reported mild to moderate hypoglycemia with pramlintide than with the RAIA (55 vs. 82%), but more patients reported nausea (21 vs. 0%).
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254407
08HumanRandomized controlled trialSafety outcome
In patients with type 2 diabetes, no severe hypoglycemia occurred with pramlintide or rapid-acting insulin.
In plain wordsIn patients with type 2 diabetes, no severe low blood sugar occurred with pramlintide or rapid-acting insulin.
Peptide
Pramlintide (Symlin)
Outcome
No significant changeSevere hypoglycemia
Study
n = 113
Comparator
Rapid-acting insulin analog
Outcome group
Adverse events · Metabolic and weight
Studied dose
120 microg · 24 weeksAs given in this study (human).
Source sentences
Summary
No severe hypoglycemia occurred in either group.
1 context sentence(design, population, supporting numbers)
Summary · context
In a 24-week open-label, multicenter study, 113 patients were randomly assigned 1:1 to addition of mealtime pramlintide (120 microg) or a titrated RAIA to basal insulin and prior oral antihyperglycemic drugs (OADs).
Report a problemFND-1950254408

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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